Ortho Dermatologics Receives FDA Approval for Altreno (tretinoin 0.05%) Lotion For Acne

Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Altreno is the first formulation of tretinoin in a lotion, and has been shown to be effective and generally well-tolerated. Altreno is expected to be available during the fourth quarter of 2018.

FDA approval of Altreno builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user's experience with the inclusion of moisturizing attributes of hyaluronic acid, glycerin and collagen," said Bill Humphries, president, Ortho Dermatologics. "Altreno lotion spreads easily and is quickly absorbed into the skin allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen."

Extensive clinical data has shown that retinoids are highly effective in treating acne and are considered a cornerstone of topical therapy. However, a common perceived barrier to their use is that treatment with retinoids is associated with skin irritation, such as dryness and peeling, and sensitivity. In clinical trials, Altreno lotion provided the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in ≤4% of patients.1,2

"Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation," said Joshua Zeichner, M.D., director, Cosmetic and Clinical Research in Dermatology, The Mount Sinai Hospital, New York City. "With the efficacy expected from a retinoid, plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients."

Ref : https://www.drugs.com/history/altreno.html

Synergy Pharmaceuticals Announces FDA Approval of Trulance (plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults

Synergy Pharmaceuticals Inc. announced  that the U.S. Food and Drug Administration (FDA) has approved Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. This is the second indication for Trulance, which is already approved for the treatment of adults with chronic idiopathic constipation (CIC).

“The IBS-C approval is a pivotal milestone for Synergy, representing the second approved indication for Trulance in the past 12 months,” said Troy Hamilton, Pharm.D., CEO of Synergy Pharmaceuticals Inc. “This approval demonstrates our unwavering commitment to provide a safe and effective treatment option for those patients living with these chronic GI disorders.”

Trulance is the only prescription medication for adults with CIC and now IBS-C that can be taken once-daily, with or without food, at any time of the day. Trulance is packaged in a unique, 30-day calendar blister pack.

“Approximately 1 in 20 Americans are living with IBS-C, many of whom are not satisfied with currently available treatment options,” said William D. Chey, M.D., Professor of Medicine, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at the University of Michigan. “With this second indication for Trulance, patients and physicians will have a much-needed, new treatment option with an established safety profile that can effectively address abdominal pain and constipation experienced by patients with IBS-C.”

“The Trulance label reflects the strong and remarkably consistent efficacy and safety profile Trulance has demonstrated in treating over 4,700 patients across both CIC and IBS-C clinical trials,” said Patrick H. Griffin, MD, Chief Medical Officer of Synergy. “To-date, real world patient experience has supported the clinical trial data, highlighted by a post-marketing diarrhea rate of less than 0.5% and no reports of severe diarrhea requiring hospitalization since the launch of the Trulance CIC indication. The IBS-C approval today builds on the already strong CIC label and further establishes Trulance as the first and only uroguanylin analog.”

With the exception of a single amino acid substitution for greater binding affinity, Trulance is structurally identical to human uroguanylin and is the only treatment thought to replicate the pH-sensitive activity of uroguanylin.

Ref : https://ir.synergypharma.com/press-releases/detail/1861/synergy-pharmaceuticals-announces-fda-approval-of

Synergy Pharmaceuticals Announces FDA Approval of Trulance (plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults

Teva Announces FDA Approval of ProAir RespiClick (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11

Teva Pharmaceutical Industries Ltd.,  announced  that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB).

ProAir RespiClick was approved by the FDA for use in patients 12 years of age and older in March 2015 and remains the only breath-activated, multi-dose, dry powder, short-acting beta-agonist (SABA) inhaler available in the U.S.

Bevespi Aerosphere Approved by the FDA for Patients with COPD

In continuation of my update on formoterol

AstraZeneca today announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

glycopyrrolate formoterol 

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurised metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, which enables patients to breathe better and may help them be more active.”

Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). The FDA approval is based on the PINNACLE trial programme, which demonstrated that Bevespi Aerosphere achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its mono-components and placebo.

Bevespi Aerosphere is the first product approved using AstraZeneca’s Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).

About COPD

COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD. It is estimated that eight out of 10 patients suffer symptoms at night, such as an irritative cough and difficulty breathing, frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.

Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties

In continuation of my update on oxycodone

Collegium Pharmaceutical, Inc.   announced that the U.S. Food and Drug Administration (FDA) approved Xtampza ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Xtampza ER is Collegium’s first product utilizing its proprietary DETERx® technology platform, and is designed to provide adequate pain control while maintaining its drug release profile after being subjected to common methods of manipulation including chewing and crushing the product prior to administration. The Xtampza ER label contains information supporting the administration of the product by sprinkling the capsule contents on soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

“The FDA approval of Xtampza ER is a major milestone for Collegium. Our DETERx technology platform was developed internally and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids. Collegium is committed to supporting responsible, appropriate prescribing for only those patients suffering from chronic pain who don’t have alternative non-opioid treatment options. Xtampza ER will provide clinicians with another treatment option for these patients,” said Michael Heffernan, CEO of Collegium.

Sun Pharma Receives FDA Approval For BromSite (bromfenac ophthalmic solution)

Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) recently announced that one of its wholly owned subsidiaries has received approval from USFDA for its New Drug Application (NDA) related to BromSite™ (bromfenac ophthalmic solution) 0.075% for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. BromSite™ is the first non-steroidal antiinflammatory drug (NSAID) approved by the USFDA to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery; other NSAIDs in this class are currently indicated for the treatment of inflammation and reduction of pain.

BromSite™ developed by InSite Vision, is the first bromfenac ophthalmic solution formulated in DuraSite™, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies. Sun Pharma acquired InSite Vision in November 2015 and is likely to commercialize BromSite™ through its newly formed, US-based division, Sun Ophthalmics, in the second half of 2016. As per IMS MAT January 2016, the U.S. NSAID Ophthalmic market grew by 8%, generating approximately US$400mn in sales and about 4 million prescriptions, providing an attractive market for Sun Pharma to participate.

Sun Ophthalmics has crossed a key business milestone through BromSite’s approval. Sun Ophthalmics targets to provide eye care practitioners products that enhance their practice patterns and treatment options and to deliver those products through its unique, concierge level approach to customer care. With BromSite’s approval and additional late-stage candidates in its pipeline, Sun Ophthalmics is strongly positioned to offer a range of beneficial products and establish itself as a respected and trusted partner.

In two multi-center, randomized, placebo-controlled Phase-3 studies, a significantly higher proportion of BromSite treated patients were pain-free at Day 1 post-surgery (77% and 82%) compared to patients treated with vehicle control (48% and 62%) (p<0.001). Additionally, a significantly higher proportion of subjects administered BromSite™ were inflammation-free at day 15 post-cataract surgery (57% and 38%), compared to a vehicle control group (19% and 22%) (p<0.001 and p=0.035).

“Over the years, I’ve worked closely with the InSite team and watched them develop multiple high quality products using the DuraSite platform,” commented Dr. Richard L. Lindstrom, MD, founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota Department of Ophthalmology. “Today, I am pleased to see BromSite™ advance from development to market. I am confident there will be significant clinician interest in this new product. As the first NSAID labeled to prevent pain and reduce inflammation post-cataract surgery, BromSite’s approval is timely and will be welcomed by patients and clinicians alike.”

Sun Pharma Receives FDA Approval For BromSite (bromfenac ophthalmic solution)

Allergan Announces FDA Approval of Aczone (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris

Allergan plc, a leading global pharmaceutical company, today announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) to market Aczone (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. Aczone Gel, 7.5% delivers proven efficacy to treat both inflammatory and non-inflammatory acne, with a new concentration of dapsone in just once-a-day application.

  (Dapsone)

"For the Aczone Gel, 7.5% pivotal trials, we studied 4,340 acne patients, demonstrating efficacy and tolerability. The new FDA product approval also offers just once-daily dosing and a new pump delivery system," said David Nicholson, Executive Vice President and President of Global R&D Brands at Allergan. "As part of Allergan's commitment to the medical dermatology space, we have truly raised the bar for ourselves in efforts to offer an effective acne product to address physician and patient needs."

In clinical trials of Aczone Gel, 7.5%, safety and efficacy were assessed in two identically designed, randomized, multi-centered, double-blind, vehicle-controlled 12-week studies. A total of 4,340 acne patients were randomized to receive either Aczone Gel, 7.5% (n=2162) or vehicle (n=2178). The majority of patients (99%; n=4339) had moderate acne, with a baseline score of 3 on the Global Acne Assessment Score (GAAS). Aczone Gel, 7.5% was approved based on co-primary endpoints of the GAAS and lesion counts (20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline). At week 12, inflammatory lesions were reduced by 15.8 lesions (54.6%; n=2162) vs 13.9 lesions with vehicle (48.1%; n=2178), and non-inflammatory lesions were reduced by 20.7 lesions (45.1%) vs 18.0 lesions with vehicle (39.4%).2 The GAAS success rate in patients was 29.8% (n=2162) vs 21.1% with vehicle (n=2178).

In addition to efficacy, Aczone Gel, 7.5% has a proven tolerability profile. Out of 2161 patients who used Aczone Gel, 7.5%, 1.1% experienced mild application-site dryness vs 1.0% with vehicle (n=2175), and 0.9% experienced pruritus vs 0.5% with vehicle.

Allergan Announces FDA Approval of Aczone (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris

Promius Pharma Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray

We know that Betamethasone dipropionate (see structure)  is a glucocorticoid steroid with anti-inflammatory and immunosuppressive abilities. It is applied as a topical cream, ointment, lotion or gel (Diprolene) to treat itching and other minor skin conditions such as eczema.

Brand names include Alphatrex, Beta-Val, Diprolene, Diprolene AF, Diprosone, and Luxiq.

Minor side effects include dry skin and mild, temporary stinging when applied.

Betamethasone dipropionate is a "super high potency" corticosteroid used to treat inflammatory skin conditions such as dermatitis, eczema andpsoriasis. It is a synthetic analog of the adrenal corticosteroids. Although its exact mechanism of action is not known, it is effective when applied topically to cortico-responsive inflammatory dermatoses...

Dr. Reddy’s announced today that its US subsidiary, Promius Pharma, LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval for Sernivo (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter.

Promius Pharma Receives FDA Approval for  ernivo (betamethasone dipropionate) Spray

Takeda receives FDA approval for NINLARO (ixazomib) capsules to treat patients with multiple myeloma

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the U.S. Food and Drug Administration (FDA) has approved NINLARO® (ixazomib) capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a once-weekly pill.

Takeda submitted a New Drug Application for NINLARO to the FDA in July 2015, and in September NINLARO was granted Priority Review status with a PDUFA date of March 10, 2016, reflecting the profound and continuing unmet need for new treatments for multiple myeloma, a devastating, relapsing and incurable rare cancer.

“With the approval of NINLARO, we can now offer patients a once-weekly oral proteasome inhibitor as part of a highly active triplet therapy,” said Paul Richardson, M.D., Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center Institute Physician at Dana-Farber Cancer Institute, and investigator for TOURMALINE-MM1, the pivotal Phase 3 trial on which today’s approval is based. “We, as investigators of the TOURMALINE-MM1 trial, felt it was vital to conduct a comprehensive ‘real world’ evaluation of this combination that included some of the most common patient types in the relapsed/refractory multiple myeloma setting, such as older patients, patients with moderate renal impairment, light chain disease, and high risk cytogenetics. Further, we treated patients until disease progression to determine the sustainability of NINLARO in treating their relapsed/refractory disease. The TOURMALINE-MM1 data demonstrate convincingly that oral NINLARO-based triplet treatment is effective at extending progression-free survival, over and above the clinical benefit seen with lenalidomide and dexamethasone, with a tolerable safety profile.”

Takeda receives FDA approval for NINLARO (ixazomib) capsules to treat patients with multiple myeloma

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

The Paediatric HIV Treatment Initiative welcomes this important step towards closing the treatment gap for children with HIV

Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration's (FDA) tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.

(lopinavir)  (ritonavir)

"The announcement of tentative FDA approval of the lopinavir/ritonavir oral pellet formulation is an important step forward in increasing access to World Health Organization-recommended antiretroviral treatment for children under three years of age," said Ambassador Deborah L. Birx, M.D., U.S. Global AIDS Coordinator and U.S. Special Representative for Global Health Diplomacy. "This supports the goals of key PEPFAR initiatives to improve paediatric HIV/AIDS services, including the Accelerating Children's HIV/AIDS Treatment Initiative and the Global Pediatric ARV Commitment to Action".

Until now, the only available version of this combination treatment was a harsh-tasting syrup that required refrigeration and contained 40% alcohol. Only a quarter of children with HIV are currently on treatment and the lack of child-adapted formulations contributes to this unacceptable situation.

"UNITAID and its partners in the Paediatric HIV Treatment Initiative (PHTI)* also welcome the approval of these oral pellets, which brings us a step nearer to closing the shameful treatment gap for the 3.2 million children living with HIV around the world," said Lelio Marmora, Executive Director of UNITAID which is funding the development of paediatric formulations for HIV.

Importantly, intellectual property issues around access to future LPV/r combinations will be reduced, thanks to a licensing agreement the Medicine Patent Pool (MPP) signed in in December 2014 with AbbVie, the patent holder for LPV/r. "This is a crucial licence for paediatric programmes as it benefits low- and middle-income countries where 99% of children with HIV in the developing world live," said Greg Perry, Executive Director of the MPP.

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

In continuation of my update on xifaxan

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan® 550 mg for the treatment of IBS-D in adults. The FDA approval of Xifaxan 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan 550 mg was studied in over 3,000 patients and demonstrated the efficacy and safety of repeat treatment following completion of a two-week course of treatment. A full course of Xifaxan 550 mg for IBS-D is available in a convenient 2 week pack of 42 pills.

"As a gastroenterologist who helps patients navigate the symptoms of IBS-D, I see the need for treatments that directly address those most bothersome, such as diarrhea and abdominal pain" said Dr. Mark Pimentel, director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai in Los Angeles. "Today's approval gives a new option to these patients and providers."

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

Actavis announces FDA approval of VIBERZI (eluxadoline) for IBS-D treatment

In continuation of my update on VIBERZI (eluxadoline)

Actavis plc,  announced today that VIBERZI™ (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). VIBERZI (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.

"The FDA's approval of VIBERZI is the first step to providing physicians with a new, evidence-based, treatment option for their adult patients with IBS-D," said David Nicholson, Executive Vice President, Actavis Global Brands R&D. "At Actavis, we are dedicated to providing new treatment options, and the development of new agents that help address the most bothersome symptoms of IBS-D. We are very pleased to be working with the FDA to advance this IBS-D treatment and we eagerly await DEA scheduling determination later this year."

Ref : http://pubchem.ncbi.nlm.nih.gov/compound/11250029#section=Canonical-SMILES

Actavis announces FDA approval of VIBERZI (eluxadoline) for IBS-D treatment

FDA Approves Glyxambi (empagliflozin and linagliptin) for Type 2 Diabetes

In continuation of my update on empagliflozin

The U.S. Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments. Glyxambi is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Glyxambi has not been studied in patients with a history of pancreatitis, and it is unknown if using Glyxambi increases the risk of developing pancreatitis in these patients.

Glyxambi is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Glyxambi has not been studied in patients with a history of pancreatitis, and it is unknown if using Glyxambi increases the risk of developing pancreatitis in these patients.

FDA Approves Glyxambi (empagliflozin and linagliptin) for Type 2 Diabetes

FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer

In continuation of my update on palbociclib

The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.

Breast cancer in women is the second most common type of cancer in the United States. It forms in the breast tissue and in advanced cases, spreads to surrounding normal tissue. The National Cancer Institute estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014.

Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. Ibrance is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women.

FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer

FDA Approves Dutrebis (lamivudine and raltegravir) for HIV-1 Infection

   

The United States Food and Drug Administration (FDA) has approved Dutrebis, a fixed dose combination tablet containing 150 mg of lamivudine and 300 mg of raltegravir. Dutrebis tablet is approved for use in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients greater than or equal to 6 years of age weighing at least 30 kg. The recommended dosage of Dutrebis is one tablet taken twice daily with or without food.

Dutrebis approval was based on an open-label, single dose, randomized, two-period, crossover study in healthy subjects (n=108). One Dutrebis fixed dose combination table was shown to provide comparable lamivudine and raltegravir exposures to one Epivir 150 mg tablet plus on Isentress 400 mg tablet. Due to the higher bioavailability of raltegravir contained in Dutrebis, the exposures provided by the 300 mg dose of raltegravir are comparable to 400 mg of ralegravir given as the raltegravir poloxamer formulation (Isentress), which accounts for the difference in raltegravir dose.

FDA Approves Dutrebis (lamivudine and raltegravir) for HIV-1 Infection

FDA Approves Lenvima (lenvatinib) for Differentiated Thyroid Cancer

LENVIMA, a kinase inhibitor, is the mesylate salt of lenvatinib. Its chemical name is 4- [3chloro-4-(N’-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carbox- amide methanesulfonate. The molecular formula is C₂₁H₁₉ClN₄O₄•CH₄O₃S, and the molecular weight of the mesylate salt is 522.96. The chemical structure of lenvatinib mesylate is:

The U.S. Food and Drug Administration today granted approval to Lenvima(lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).

FDA Approves Lenvima (lenvatinib) for Differentiated Thyroid Cancer

Alcon Receives FDA Approval of Pazeo (olopatadine HCl) Ophthalmic Solution for Allergic Conjunctivitis

Olopatadine hydrochloride is an antihistamine (as well as anticholinergic and mast cell stabilizer), sold as a prescription eye drop (0.2% solution, Pataday (or Patanol S in some countries), manufactured by Alcon). It is used to treat itching associated with allergic conjunctivitis (eye  allergies). Olopatadine hydrochloride 0.1% is sold as Patanol (or Opatanol in some countries). A decongestant nasal spray formulation is sold as Patanase, which was approved by the FDA on April 15, 2008.  It is also available as an oral tablet in Japan under the tradename Allelock, manufactured by Kyowa Hakko Kogyo.

Alcon, the global leader in eye care and a division of Novartis, has received approval from the U.S. Food and Drug Administration (FDA) of Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, for the treatment of ocular itching associated with allergic conjunctivitis. Pazeo solution is dosed one drop daily, and was approved with efficacy data at 24 hours, post dose.

Alcon Receives FDA Approval of Pazeo (olopatadine HCl) Ophthalmic Solution for Allergic Conjunctivitis

Mylan announces U.S. launch of Celecoxib Capsules

In continuation of my update celecoxib

Mylan Inc. (Nasdaq: MYL)      announced the U.S. launch of its Celecoxib Capsules,   50 mg,  100 mg,  200 mg, and 400 mg,  one  of the  first  available  generic  versions        of   Pfizer's elebrex®       Capsules,     which    is   indicated for  the  relief  of the  signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.

Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, had U.S. sales of approximately $2.5 billion for the 12 months ending September 30, 2014, according to IMS Health.

Currently, Mylan has 286 ANDAs pending FDA approval representing $111.6 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $29.5 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.

Mylan announces U.S. launch of Celecoxib Capsules

Harvoni Approved for Chronic Hepatitis C

In continuation of my update on  ledipasvir and sofosbuvir (Harvoni-combination pill) 

Harvoni, a daily pill that treats the most common form of hepatitis C, was approved by the U.S. Food and Drug Administration on Friday.

It's the first combination pill (ledipasvir and sofosbuvir) approved to treat the chronic infection, and the first medication that doesn't require that the antiviral drugs interferon or ribavirin be taken at the same time, the FDA said in a news release.

Both drugs in the combination pill interfere with the hepatitis C virus' ability to multiply. One of the drugs, sofosbuvir (Sovaldi) was approved in December 2013, while ledipasvir is a new antiviral, the agency said.

"With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the news release. "Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens."

One expert applauded Harvoni's approval.

"This is a giant step forward for people with [hepatitis C]. One pill, once daily, no interferon, no ribavirin and 94 to 99 percent cure! It moves the risk-benefit ratio needle way over toward benefit," said Dr. Douglas Dieterich, a professor of medicine in the division of liver diseases at The Mount Sinai Hospital in New York City.

However, price has been an issue with some of the new treatments for hepatitis C. For example, Sovaldi alone costs $1,000 a day and not all insurance companies cover the cost of treatment, experts have noted. Harvoni will cost $1,125 a pill, the Associated Press reported Friday.

Hepatitis C causes inflammation of the liver, which could spark other problems including diminished liver function (cirrhosis), scarring, liver cancer or liver failure. Most infected people aren't aware that they carry the virus until liver damage has occurred, the agency said.

Some 3.2 million Americans are believed to be infected with hepatitis C, the FDA said.

Harvoni was evaluated in three clinical studies involving more than 1,500 people who either hadn't been treated previously or hadn't responded to prior treatment. The most common side effects were fatigue and headache.

Harvoni Approved for Chronic Hepatitis C  

Flamel Technologies Announces FDA Approval of Bloxiverz

Flamel Technologies today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Bloxiverz (neostigmine (see structure below) methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch Bloxiverz in July 2013 in 0.5 and 1.0 mg/mL strengths.

"We are extremely excited and pleased to receive this FDA approval for Bloxiverz, the first product from the portfolio of Éclat products acquired in March 2012," said Mike Anderson, Chief Executive Officer of Flamel.

Bloxiverz is the first FDA-approved version of neostigmine, even though other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug and Cosmetic Act of 1938. Today, neostigmine is the most common agent used for the reversal of the effects of other agents used for neuromuscular blocks.

Flamel Technologies Announces FDA Approval of Bloxiverz