Drugs.com - New Drug Approvals

Lilly Receives Fourth FDA Approval for Alimta (pemetrexed for injection) as Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer

Tue, 07 Jul 2009 14:03:04 GMT

ALIMTA First Chemotherapy Approved As Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer INDIANAPOLIS, July 6 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE:LLY) announced today it received a fourth approval from the U.S....

FDA Approves Multaq for Patients with Atrial Fibrillation or Atrial Flutter

Thu, 02 Jul 2009 14:30:26 GMT

PARIS, July 02, 2009 /PRNewswire-FirstCall/ --Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will...

FDA Approves Feraheme to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients

Tue, 30 Jun 2009 04:00:00 GMT

LEXINGTON, Mass.--(BUSINESS WIRE)-- AMAG Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Feraheme (ferumoxytol) Injection for intravenous (IV) use as an iron replacement...

FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under

Thu, 25 Jun 2009 11:49:31 GMT

ROCKVILLE, Md., June 24, 2009--The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for...

FDA Approves Cambia for Migraine

Tue, 23 Jun 2009 15:46:08 GMT

MONTGOMERY, Ala.--(BUSINESS WIRE)--Jun 22, 2009 - Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has...

Allergan Receives FDA Approval for Ozurdex Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease

Thu, 18 Jun 2009 14:48:40 GMT

IRVINE, Calif.--(BUSINESS WIRE)--Jun 18, 2009 - Allergan, Inc. today announced that the United States Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the...

New Biological Therapy Ilaris Approved In US To Treat Children And Adults With CAPS, A Serious Life-Long Auto-Inflammatory Disease

Thu, 18 Jun 2009 13:44:04 GMT

BASEL, Switzerland, June 18, 2009 - The US Food and Drug Administration (FDA) has approved Ilaris (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but...

Xanodyne Receives Approval From the U.S. Food and Drug Administration for Zipsor (diclofenac potassium) Liquid Filled Capsules

Wed, 17 Jun 2009 12:25:03 GMT

NEWPORT, Ky., June 17, 2009 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for Zipsor (diclofenac potassium) Liquid Filled Capsules, a new treatment...

Cumberland Pharmaceuticals Announces FDA Approval of Caldolor

Fri, 12 Jun 2009 14:20:10 GMT

New drug is first injectable product approved for sale in the United States for treatment of pain and fever NASHVILLE, Tenn., June 11 /PRNewswire/ -- Cumberland Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) has...

Emergent BioSolutions Receives FDA Approval Extending Shelf Life of BioThrax (Anthrax Vaccine Adsorbed) to 4 Years

Thu, 11 Jun 2009 13:56:45 GMT

ROCKVILLE, Md.--(BUSINESS WIRE)--Jun 10, 2009 - Emergent BioSolutions Inc. (NYSE:EBS) announced today that its flagship product, BioThrax (Anthrax Vaccine Adsorbed), has been granted a shelf life extension from 3 to 4 years by the U.S. Food and Drug...

FDA Approves 12-Month Labeling Update for Evolence Collagen-Based Facial Filler

Wed, 10 Jun 2009 13:49:13 GMT

HERZLIYA, Israel and SKILLMAN, N.J., June 8 /PRNewswire/ -- Ortho Dermatologics today announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement which includes efficacy and safety data through 12 months for Evolence, a...

Axert (almotriptan) Approved by the FDA for the Treatment of Migraine in Adolescents

Wed, 03 Jun 2009 16:50:20 GMT

Axert (almotriptan) is the first of its class to be approved for treatment of migraine in adolescents by the Food and Drug Administration (FDA). Axert (almotriptan) was approved in adults, in USA, in 2001. It is estimated that up to 10% of...

FDA Approves Labeling Change for Vyvanse (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

Mon, 01 Jun 2009 14:15:21 GMT

ADHD symptom control demonstrated from the first time point measured (1.5 hours) through 13 hours postdose PHILADELPHIA, June 1 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, today announced that the US Food...

FDA Approves Lamictal XR; An Extended-Release Once-Daily, New Generation Treatment for Epilepsy

Mon, 01 Jun 2009 14:10:09 GMT

RESEARCH TRIANGLE PARK, N.C., June 1 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Lamictal XR (lamotrigine) Extended-Release Tablets as once-a-day add-on therapy for epilepsy...

FDA Approves Reclast to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing

Mon, 01 Jun 2009 12:25:43 GMT

Single infusion of Reclast increases bone mass for two years in postmenopausal women with osteopenia, a condition that can lead to osteoporosis(1) Approximately 22 million women in US have osteopenia, or low bone mass, putting them at increased risk...

Bausch & Lomb Receives FDA Approval of Besivance, New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye')

Fri, 29 May 2009 13:35:54 GMT

Besivance Adds to Bausch & Lomb's Expanding Ocular Pharmaceuticals Portfolio and Offers New Therapeutic Option for a Wide Range of Ocular Bacterial Pathogens(1) MADISON, N.J., May 29 /PRNewswire/ -- Bausch & Lomb, a world leader in eye health, today...

Astellas Receives FDA Approval for Use of Prograf (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients

Thu, 28 May 2009 14:10:29 GMT

DEERFIELD, Ill., May 28 /PRNewswire/ -- The Food and Drug Administration (FDA) has granted Astellas Pharma US, Inc. approval for the use of Prograf (tacrolimus) in conjunction with mycophenolate mofetil (MMF) for the prevention of organ rejection in...

FDA Grants Full Approval for Sprycel (dasatinib) for the Treatment of Adults with Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Prior Therapies Including Gleevec

Tue, 26 May 2009 20:10:25 GMT

Two-Year Follow-Up Data Includes 80 Percent Progression-Free Survival Rate in Gleevec-Resistant or Intolerant Patients with Chronic Phase CML NEW YORK--(BUSINESS WIRE)--May 26, 2009 - Bristol-Myers Squibb Company today announced that the U.S. Food...

FDA Approves Adcirca (tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension

Tue, 26 May 2009 13:44:21 GMT

SILVER SPRING, Md., May 26 /PRNewswire-FirstCall/ -- United Therapeutics Corporation announced today that the United States Food and Drug Administration (FDA) has approved Adcirca (tadalafil) tablets for oral administration, with a recommended dose...

FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia

Fri, 22 May 2009 13:11:22 GMT

TOKYO and PRINCETON, N.J., May 21 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) announced today that the U.S. Food and Drug Administration (FDA) has approved Samsca...

FDA Grants Approval for Use of Risperdal Consta as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder

Mon, 18 May 2009 16:29:03 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 18, 2009 - Alkermes, Inc. today announced that Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has received approval from the U.S. Food and Drug Administration (FDA) for the use of...

Novartis Receives Approval From FDA To Market Prevacid 24HR As First And Only OTC Proton Pump Inhibitor In Original Prescription Formulation

Thu, 14 May 2009 15:50:21 GMT

* This approval will provide greater convenience and broader access to an effective treatment option to the 50 million Americans[1] suffering from frequent heartburn * Once-daily, prescription-strength Prevacid 24HR is the first OTC proton pump...

UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis

Wed, 13 May 2009 06:00:00 GMT

- Available this week, Cimzia (certolizumab pegol), the only pegylated anti-TNF, offers a new treatment option for U.S. adult patients suffering from moderately to severely active rheumatoid arthritis - Patients treated with Cimzia, together with...

FDA Approves ACTOplus met XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes

Wed, 13 May 2009 05:00:00 GMT

First and only oral antidiabetic fixed-dose combination medication approved with the extended-release form of metformin DEERFIELD, Ill. and OSAKA, Japan, May 13 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary,...

Azor Receives FDA Approval as First-Line Treatment for High Blood Pressure

Wed, 13 May 2009 04:00:00 GMT

Fixed-dose combination offers a convenient option that may help patients reduce steps to reach their blood pressure goals while decreasing patient pill burden(1) PARSIPPANY, N.J., May 13 /PRNewswire/ -- Daiichi Sankyo, Inc. today announced that the...

FDA Approves Lamictal ODT Orally Disintegrating Tablets

Mon, 11 May 2009 13:15:57 GMT

- Easy-to-swallow formulation provides important new alternative for patients RESEARCH TRIANGLE PARK, N.C., May 11 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved Lamictal ODT...

FDA Approves Fanapt to Treat Schizophrenia

Thu, 07 May 2009 11:55:32 GMT

ROCKVILLE, Md., May 6, 2009--The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder. "Schizophrenia can be a devastating illness requiring...

VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes

Wed, 06 May 2009 15:38:45 GMT

First-in-class antidiabetic drug is first to receive FDA approval under new cardiovascular safety guidelines TIVERTON, R.I. & BRISTOL, Tenn.--(BUSINESS WIRE)--May 6, 2009 - VeroScience, in collaboration with S2 Therapeutics, Inc. (S2), announced...

FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy

Wed, 06 May 2009 13:55:20 GMT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 5, 2009 - Genentech, Inc. announced today that the U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with glioblastoma with progressive disease...

Creon (pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines

Fri, 01 May 2009 15:27:38 GMT

– Therapy is medically-necessary for thousands of patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions – MARIETTA, Ga., May 1, 2009 – Solvay Pharmaceuticals, Inc. today announced that the U.S. Food and...

FDA Approves Cetraxal Otic Solution

Fri, 01 May 2009 04:00:00 GMT

May 1, 2009 - The United States Food and Drug Administation has approved Cetraxal (ciprofloxacin otic solution) 0.2% for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aerugenosa or Staphylococcus aureus. More...

FDA approves Exforge HCT - the only high blood pressure treatment to combine three medications in a single pill

Thu, 30 Apr 2009 21:34:42 GMT

Basel, Switzerland, 30 April, 2009 — The US Food and Drug Administration (FDA) has approved Exforge HCT, the only single pill to combine the three most prescribed high blood pressure treatments in their classes in the US(3): the calcium channel...

FDA Approves Dysport for Therapeutic and Aesthetic Uses

Thu, 30 Apr 2009 13:45:01 GMT

SCOTTSDALE, Arizona and PARIS, France — April 30, 2009 — Medicis and Ipsen today announced the U.S. Food and Drug Administration's (FDA) approval of the Biologics License Application (BLA) for Dysport (abobotulinumtoxinA), an acetylcholine...

Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Fri, 24 Apr 2009 22:58:19 GMT

HORSHAM, Pa., April 24 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi (golimumab) for the treatment of moderately to severely active rheumatoid arthritis, active...

Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment

Mon, 13 Apr 2009 14:51:21 GMT

ATLANTA--(BUSINESS WIRE)--Apr 13, 2009 - Sciele Pharma, Inc., a Shionogi Company, today announced that the U.S. Food & Drug Administration (FDA) has approved Benzyl Alcohol Lotion 5%, the first and only prescription medication that kills head lice...

Coartem receives FDA approval becoming first artemisinin-based combination treatment (ACT) for malaria in the US

Wed, 08 Apr 2009 20:34:43 GMT

* Coartem is highly effective, well tolerated 3-day treatment with cure rates of over 96% * More than 235 million Coartem treatments already supplied by Novartis for public sector use in Africa, helping save an estimated 600,000 lives Basel, April...

Bioject Announces FDA Market Clearance for the Zetajet Needle-Free Injection Therapy System

Mon, 06 Apr 2009 19:35:08 GMT

PORTLAND, Ore.--(BUSINESS WIRE)--Apr 6, 2009 - Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of needle-free injection therapy systems, today announced that the U.S. Food and Drug Administration (FDA) has granted market...

Intercell Announces FDA Approval of Ixiaro, a Novel Vaccine to Prevent Japanese Encephalitis

Tue, 31 Mar 2009 13:59:21 GMT

VIENNA, March 30, 2009 /PRNewswire/ -- Intercell AG today announced that the U.S. Food and Drug Administration (FDA) approved Ixiaro, a new vaccine for the prevention of Japanese Encephalitis (JE). The initial target for use of Intercell's vaccine -...

Afinitor approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib

Mon, 30 Mar 2009 04:00:00 GMT

Afinitor more than doubled time without tumor growth and reduced the risk of disease progression or death by 67% compared with placebo Only once-daily oral cancer treatment to directly target mTOR, a protein inside the cell that controls tumor...

FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

Tue, 24 Mar 2009 20:50:11 GMT

COLLEGEVILLE, Pa., March 24, 2009 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) approved Tygacil (tigecycline), for the treatment of adult patients with...