Drugs.com - New Drug Approvals

FDA Approves Labeling Update for Reyataz (atazanavir sulfate) Capsules to Include 96-Week Data for Previously Untreated HIV-1 Infected Adult Patients

Fri, 06 Nov 2009 15:46:34 GMT

PRINCETON, N.J.--(BUSINESS WIRE)--Nov 5, 2009 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Reyataz to include long-term data from the CASTLE Study. The CASTLE...

FDA Approves Gloucester Pharmaceuticals' Istodax for Patients with Cutaneous T-cell Lymphoma

Fri, 06 Nov 2009 15:46:08 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 5, 2009 - Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have...

FDA Approves Pennsaid Topical Solution

Thu, 05 Nov 2009 12:35:29 GMT

ST. LOUIS & MISSISSAUGA, Ontario--(BUSINESS WIRE)--Nov 5, 2009 - Covidien, a leading global provider of healthcare products, and Nuvo Research Inc., a Canadian drug development company, today announced that the U.S. Food and Drug Administration...

Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes

Mon, 02 Nov 2009 14:37:54 GMT

SAN DIEGO and INDIANAPOLIS, Oct. 30, 2009 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Byetta (exenatide)...

FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia

Tue, 27 Oct 2009 00:45:38 GMT

SILVER SPRING. Md., Oct. 26 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone...

FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares

Thu, 22 Oct 2009 21:16:21 GMT

New Colchicine Formulation Significantly Reduces Side Effects, Maintains Full Efficacy; Now Indicated for Both Prophylaxis and Treatment of Gout Flares PHILADELPHIA, Oct. 19 /PRNewswire/ -- URL Pharma, Inc., today announced that the U.S. Food...

FDA Approves GlaxoSmithKline’s Votrient for Advanced Renal Cell Cancer

Tue, 20 Oct 2009 03:00:00 GMT

PHILADELPHIA, October 20, 2009 - GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved Votrient (pazopanib) to treat patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. Approximately...

FDA Approves Twynsta (telmisartan/amlodipine) for Hypertension

Mon, 19 Oct 2009 09:00:00 GMT

FDA Approves New Use for Micardis in Cardiovascular Risk Reduction and Twynsta as New Combination Treatment for High Blood Pressure Ridgefield, CT, October 19, 2009 - Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food...

FDA Approves New Use for Micardis in Cardiovascular Risk Reduction

Mon, 19 Oct 2009 08:00:00 GMT

RIDGEFIELD, Conn., Oct. 19 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker...

FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

Mon, 19 Oct 2009 05:00:00 GMT

SILVER SPRING, Md., Oct. 19 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated...

Talecris Biotherapeutics Receives FDA Approval for Prolastin-C

Mon, 19 Oct 2009 04:00:00 GMT

RESEARCH TRIANGLE PARK, N.C., Oct. 19 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics today received approval from the U.S. Food and Drug Administration for Prolastin-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of...

FDA Approves Elitek (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy

Sat, 17 Oct 2009 00:05:44 GMT

- Elitek is now approved to manage a potentially life-threatening complication associated with anti-cancer treatment in adults - BRIDGEWATER, N.J., Oct. 16 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced that the U.S. Food and...

FDA Approves Gardasil for Use in Boys and Young Men

Fri, 16 Oct 2009 18:34:17 GMT

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Oct 16, 2009 - Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]...

FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine

Fri, 16 Oct 2009 16:25:18 GMT

LONDON, Oct. 16, 2009--GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical...

U.S. Food and Drug Administration Approves Crestor for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

Fri, 16 Oct 2009 13:30:28 GMT

WILMINGTON, Del., Oct. 16 /PRNewswire-FirstCall/ -- AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved Crestor (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial...

CSL Behring Announces FDA Approval of Berinert, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.

Mon, 12 Oct 2009 13:50:07 GMT

KING OF PRUSSIA, Pa., Oct. 12 /PRNewswire/ -- CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert C1-Esterase Inhibitor, Human for the treatment of acute abdominal or...

Welchol (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia

Wed, 07 Oct 2009 15:34:34 GMT

Welchol for Oral Suspension Also Approved by FDA PARSIPPANY, N.J., Oct. 7 /PRNewswire/ -- Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA)...

FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users

Fri, 02 Oct 2009 12:11:41 GMT

ROCKVILLE, Md., Oct. 1, 2009--The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy...

FDA Approves Stelara (ustekinumab) to Treat Psoriasis

Fri, 25 Sep 2009 19:24:45 GMT

September 25, 2009 - The U.S. Food and Drug Administration today approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis. Plaque psoriasis is an immune system disorder that results in the rapid...

FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma

Fri, 25 Sep 2009 15:33:03 GMT

SILVER SPRING, Md., Sept. 25 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has approved Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of...

Novartis receives FDA approval for Valturna, a single-pill combination of valsartan and aliskiren, to treat high blood pressure

Thu, 17 Sep 2009 21:15:58 GMT

Basel, September 17, 2009 - The US Food and Drug Administration (FDA) has approved Valturna (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system, also known as the renin angiotensin...

FDA Approves Vaccines for 2009 H1N1 Influenza Virus

Wed, 16 Sep 2009 11:49:18 GMT

ROCKVILLE, Md., Sept. 15,2009--The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become...

Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis

Wed, 16 Sep 2009 04:00:00 GMT

TAMPA, FL, September 16, 2009 – Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has approved its New Drug Application for Zirgan (ganciclovir...

Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections

Sun, 13 Sep 2009 22:30:48 GMT

SOUTH SAN FRANCISCO, CA and DEERFIELD, IL - September 11, 2009 - Theravance, Inc. and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Vibativ (telavancin) for the treatment of adult patients...

Ista Pharmaceuticals' Bepreve Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies

Wed, 09 Sep 2009 14:35:08 GMT

IRVINE, Calif., September 08, 2009 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription...

Salix Receives FDA Marketing Approval for Metozolv ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD

Tue, 08 Sep 2009 19:59:42 GMT

RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for Metozolv ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. Metozolv ODT...

FDA Approves Zevalin Expanded Label as Part of First-Line Therapy in Treatment of Follicular Non-Hodgkin's Lymphoma

Fri, 04 Sep 2009 19:30:09 GMT

IRVINE, Calif.--(BUSINESS WIRE)--Sep 4, 2009 - Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a focus in oncology, today announced Zevalin (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received...

Shire Announces FDA Approval of Once-Daily Intuniv (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17

Thu, 03 Sep 2009 14:14:20 GMT

PHILADELPHIA, September 3/PRNewswire-FirstCall/ -- Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for Intuniv (guanfacine) Extended Release...

Meda Receives FDA Approval of New Astepro (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine

Wed, 02 Sep 2009 13:21:02 GMT

SOMERSET, N.J., Sept. 2 /PRNewswire/ -- Meda Pharmaceuticals Inc. today announced that the US Food and Drug Administration (FDA) has approved Astepro (azelastine HCl) Nasal Spray 0.15%, for the treatment of the symptoms of seasonal and perennial...

FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants

Mon, 31 Aug 2009 14:56:41 GMT

- Plus new oral solution offers dosing flexibility for pediatric patients - NUTLEY, N.J., Aug. 31 /PRNewswire-FirstCall/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved...

Eurand Granted FDA Approval for Zenpep

Fri, 28 Aug 2009 04:00:00 GMT

PHILADELPHIA, PA, Aug 28, 2009 -- Eurand N.V., a specialty pharmaceutical company, today announced U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Zenpep (pancrelipase) Delayed-Release Capsules for the...

FDA Approves Xyzal For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria

Tue, 25 Aug 2009 14:56:04 GMT

ATLANTA and BRIDGEWATER, N.J., Aug. 24 /PRNewswire/ -- UCB and sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved Xyzal (levocetirizine dihydrochloride) for children age six months and older for...

Lundbeck Inc. Announces FDA Marketing Approval for Sabril for the Treatment of Two Difficult-to-Treat Epilepsies

Fri, 21 Aug 2009 18:55:35 GMT

DEERFIELD, Ill.--(BUSINESS WIRE)--Aug 21, 2009 - Lundbeck Inc. ("Lundbeck"), a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen: LUN), announced today that the U.S. Food and Drug Administration (FDA) has granted two New...

FDA Approves GSK's Hib Vaccine, Hiberix

Thu, 20 Aug 2009 13:53:07 GMT

PHILADELPHIA, Aug. 19 /PRNewswire-FirstCall/ -- In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline (NYSE:GSK) has received accelerated approval from the FDA (Food and Drug...

Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A

Tue, 18 Aug 2009 14:15:07 GMT

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Aug 17, 2009 - CSL Behring announced today that Helixate® FS, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children...

US FDA Approves Extavia - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with This Devastating Disease

Mon, 17 Aug 2009 13:07:35 GMT

Basel, August 17, 2009 - The US Food and Drug Administration (FDA) has approved Extavia (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating...

Schering-Plough Announces FDA Approval of Saphris (asenapine)

Fri, 14 Aug 2009 14:05:29 GMT

KENILWORTH, N.J., Aug. 14 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Saphris (asenapine) sublingual tablets for acute treatment of schizophrenia in adults...

FDA Approves Embeda For Management of Moderate to Severe Chronic Pain

Thu, 13 Aug 2009 21:13:58 GMT

BRISTOL, Tenn., Aug. 13 /PRNewswire-FirstCall/ -- King Pharmaceuticals , Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral...

Tracleer receives label extension in the US for the treatment of patients with mildly symptomatic WHO Functional Class II pulmonary arterial hypertension

Tue, 11 Aug 2009 20:37:00 GMT

Tracleer® indication expansion underscores importance of early screening and treatment to improve outcomes ALLSCHWIL, SWITZERLAND - 10 August 2009 - Actelion Ltd (SIX: ATLN) announced today that the U.S. Food and Drug Administration (FDA) has...

FDA Approves New 3000 IU Vial Size for Kogenate FS, antihemophilic factor (recombinant)

Fri, 07 Aug 2009 13:35:29 GMT

Larger Vial Provides Greater Convenience for Patients Requiring Higher Dose WAYNE, N.J., Aug. 7 /PRNewswire/ -- Today, Bayer HealthCare Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a 3000 IU...