Drugs.com - New Drug Approvals

U.S. Food and Drug Administration Approves Abilify (aripiprazole) for Add-On Treatment to Lithium or Valproate in the Acute Treatment of Adults With Manic and Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features

Fri, 09 May 2008 13:50:34 GMT

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--May 8, 2008 - Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved updated labeling for Abilify (aripiprazole) as an...

Abilify (aripiprazole) Receives Expanded Indications for Maintenance Treatment in Both Pediatric Patients (Aged 10-17) With Manic and Mixed Episodes of Bipolar I Disorder and Adolescents (Aged 13-17) With Schizophrenia

Fri, 09 May 2008 13:45:27 GMT

TOKYO & PRINCETON, N.J.--(BUSINESS WIRE)--May 8, 2008 - Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced that Abilify (aripiprazole) received expanded indications in Bipolar I Disorder and Schizophrenia. Abilify is...

FDA Approves Strattera for Maintenance of ADHD in Children and Adolescents

Thu, 08 May 2008 13:45:39 GMT

First Medication Indicated for Maintenance Treatment for ADHD INDIANAPOLIS, May 08, 2008 /PRNewswire-FirstCall/ -- Eli Lilly and Company announced today that the United States Food and Drug Administration (FDA) has approved Strattera (atomoxetine...

Trudell Aerocount Innovation to Benefit U.S. Asthma Patients

Wed, 07 May 2008 14:30:24 GMT

Aerocount Dose Indicator integrated with the Alvesco (ciclesonide) Inhalation Aerosol for the U.S. Market LONDON, Canada (7-May-08) - Trudell Medical International is pleased to announce the FDA approval of Alvesco (ciclesonide) inhalation...

FDA Approves Advair 250/50 for Reduction of Exacerbations in Patients With COPD

Thu, 01 May 2008 13:45:17 GMT

Advair 250/50 Now the Only Treatment Approved to Both Reduce Exacerbations and Improve Lung Function RESEARCH TRIANGLE PARK, N.C., April 30, 2008 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration today approved Advair Diskus 250/50...

FDA Approves Mixject, a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceutical's Trelstar Depot and Trelstar LA

Wed, 30 Apr 2008 14:35:30 GMT

New system addresses the needs of the medical community; builds on proven efficacy and safety of Trelstar CORONA, Calif., April 30, 2008 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical...

Sucampo Pharmaceuticals Obtains FDA Approval for Amitiza for the Treatment of Irritable Bowel Syndrome with Constipation in Adult Women

Wed, 30 Apr 2008 12:00:03 GMT

BETHESDA, Md. & DEERFIELD, Ill. & OSAKA, Japan--(BUSINESS WIRE)--April 29, 2008 - Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced...

FDA Approves Second Improvement to Unigene's Calcitonin Manufacturing Process

Tue, 29 Apr 2008 12:45:06 GMT

FAIRFIELD, N.J.--(BUSINESS WIRE)--Apr 29, 2008 - The U.S. Food and Drug Administration (FDA) has approved the use of a new clone for the manufacture of calcitonin, the active ingredient in Fortical(R), Unigene Laboratories, Inc.'s (OTCBB:...

Progenics and Wyeth Announce FDA Has Approved Relistor

Fri, 25 Apr 2008 13:50:22 GMT

TARRYTOWN, N.Y. & COLLEGEVILLE, Pa.--(BUSINESS WIRE)--April 25, 2008 - Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth, today announced that the U.S. Food and Drug Administration (FDA) has approved Relistor...

FDA Approves New Once-a-Month Dose of Actonel for Postmenopausal Osteoporosis

Fri, 25 Apr 2008 13:36:00 GMT

CINCINNATI and BRIDGEWATER, N.J., April 24, 2008 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) approved a new once-a-month dose (150 mg) of Actonel (risedronate sodium) tablets for the treatment and prevention...

Biovail Receives FDA Approval for Aplenzin (BVF-033)

Thu, 24 Apr 2008 12:50:42 GMT

TORONTO--(BUSINESS WIRE)--Apr 23, 2008 - Biovail Corporation announced today that it has received Approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for Aplenzin (formerly known as BVF-033), a...

FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults

Wed, 23 Apr 2008 17:05:01 GMT

Within the First Eight Months Since its Introduction in the United States, Vyvanse has Achieved Over One Million Prescriptions BASINGSTOKE, England and PHILADELPHIA, April 23, 2008 /PRNewswire-FirstCall/ -- Shire plc , the global...

Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease

Tue, 22 Apr 2008 20:40:11 GMT

BRUSSELS (Belgium) - April 22, 2008 UCB announced today that the US Food and Drug Administration (FDA) has approved Cimzia (certolizumab pegol), the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha) antibody indicated for reducing...

Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine

Wed, 16 Apr 2008 13:45:30 GMT

LONDON, April 15, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline and POZEN Inc. announced today that the FDA has approved Treximet for the acute treatment of migraine attacks with or without aura in adults. Treximet is the first and only migraine...

Alcon's Patanase Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms

Wed, 16 Apr 2008 13:10:33 GMT

HUENENBERG, Switzerland, April 15, 2008 /PRNewswire-FirstCall/ -- Alcon, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Patanase (olopatadine hydrochloride) nasal spray for the relief of the symptoms...

CV Therapeutics and Astellas Announce FDA Approval for Lexiscan (regadenoson) Injection

Fri, 11 Apr 2008 12:55:22 GMT

PALO ALTO, Calif. and DEERFIELD, Ill., April 10, 2008 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. and Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Lexiscan (regadenoson) injection, an...

U.S. Food and Drug Administration Approves Orencia (abatacept) for the Treatment of Moderate-to-severe Polyarticular Juvenile Idiopathic Arthritis in Patients Six Years and Older

Wed, 09 Apr 2008 13:35:11 GMT

PRINCETON, NJ, April 8, 2008 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved Orencia (abatacept) for reducing signs and symptoms in pediatric patients six years and older with moderately...

FDA Approves Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus

Fri, 04 Apr 2008 13:15:55 GMT

ROCKVILLE, Md., April 3, 2008-The U.S. Food and Drug Administration today announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea)...

Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia

Thu, 20 Mar 2008 17:00:45 GMT

First New Agent for CLL Patients Approved by the FDA since 2001 FRAZER, Pa., March 20, 2008 /PRNewswire-FirstCall/ -- Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Treanda (bendamustine hydrochloride)...

FDA Approves Artiss Medical Adhesive to Treat Burn Patients

Wed, 19 Mar 2008 04:00:00 GMT

The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients. Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and...

FDA Approval for Autoinjector

Wed, 12 Mar 2008 20:25:28 GMT

SHEFFIELD, England, 11 March 2008--The Medical House PLC), the drug delivery specialist, is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Groups Compact AutoSafety Injector...

Perrigo Company Receives Final Approval on Clobetasol Propionate Foam

Tue, 11 Mar 2008 21:50:51 GMT

ALLEGAN, Mich., March 11, 2008 /PRNewswire-FirstCall/ -- Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol...

FDA Approves New Drug Application for Levoleucovorin, Spectrum's First Proprietary Oncology Drug

Mon, 10 Mar 2008 13:00:45 GMT

IRVINE, Calif.--(BUSINESS WIRE)--Mar 7, 2008 -Spectrum Pharmaceuticals, Inc. today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Levoleucovorin for Injection. It is indicated after...

FDA Approves Aloxi (palonosetron HCl) Injection for Prevention of Postoperative Nausea and Vomiting

Mon, 03 Mar 2008 12:40:58 GMT

WOODCLIFF LAKE, N.J., March 02, 2008 /PRNewswire/ -- Eisai Corporation of North America, its U.S. subsidiary, MGI Pharma, INC., and Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved Aloxi...

FDA Approves Pristiq for the Treatment of Adult Patients with Major Depressive Disorder

Mon, 03 Mar 2008 12:40:55 GMT

MADISON, N.J., February 29, 2008 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has approved Pristiq (desvenlafaxine), a structurally novel,...

U.S. Food and Drug Administration Approves Abilify (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

Fri, 29 Feb 2008 14:00:42 GMT

TOKYO and PRINCETON, N.J., February 29, 2008 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for...

FDA Approves Luvox CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder and Obsessive Compulsive Disorder

Fri, 29 Feb 2008 13:15:10 GMT

PALO ALTO, Calif., February 28, 2008 /PRNewswire-FirstCall/ -- Today, Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Once-A-Day Luvox CR (fluvoxamine maleate) Extended-Release Capsules for the...

FDA Approves Arcalyst - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Thu, 28 Feb 2008 12:30:28 GMT

ROCKVILLE, Md., Feb. 27, 2008--The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for...

FDA Approves Nexium for Use in Children Ages 1-11 Years

Thu, 28 Feb 2008 12:25:14 GMT

ROCKVILLE, Md., Feb. 28, 2008--The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved...

FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer

Mon, 25 Feb 2008 13:05:50 GMT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Feb 22, 2008 - Genentech, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Avastin (bevacizumab), in combination with paclitaxel chemotherapy,...

Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis

Fri, 22 Feb 2008 15:30:28 GMT

ABBOTT PARK, Ill., February 22, 2008 /PRNewswire-FirstCall/ -- Abbott announced today it has received U.S. Food and Drug Administration (FDA) approval to market Humira (adalimumab) as a treatment to reduce signs and symptoms of moderately to...

FDA Licenses Xyntha, a New Hemophilia Treatment

Thu, 21 Feb 2008 18:25:08 GMT

ROCKVILLE, Md., Feb. 21, 2008--The U.S. Food and Drug Administration today licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the...

FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria

Tue, 19 Feb 2008 13:00:56 GMT

BRUSSELS, Belgium and PARIS, February 19, 2008 at 8:00 am CET - UCB and sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/mL...

Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management

Tue, 19 Feb 2008 12:10:43 GMT

ABBOTT PARK, Ill., February 15, 2008 /PRNewswire-FirstCall/ -- Today, Abbott received U.S. Food and Drug Administration (FDA) approval for Simcor, the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan...

HIV/AIDS Update - Epivir Tablets for Pediatric Dosing

Thu, 07 Feb 2008 16:45:15 GMT

ROCKVILLE, Md., Feb. 7, 2008--FDA has approved a new formulation of Epivir (lamivudine) designed to facilitate dosing in appropriate pediatric patients who can reliably swallow tablets. Epivir is now available as 150 mg scored tablets. The scored...

FDA Approves Asmanex Twisthaler (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11

Mon, 04 Feb 2008 13:40:02 GMT

KENILWORTH, N.J., February 04, 2008 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Asmanex Twisthaler 110 mcg (mometasone furoate inhalation powder) for the...

Medtronic Receives FDA Approval for Endeavor Zotarolimus-Eluting Coronary Stent System

Fri, 01 Feb 2008 18:50:06 GMT

MINNEAPOLIS--(BUSINESS WIRE)--Feb 1, 2008 - Marking a major development in the field of interventional cardiology, Medtronic, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for...

FDA Approves Emend (fosaprepitant dimeglumine) for Injection, Merck's New Intravenous Therapy, for Use in Combination with Other Antiemetics for Prevention of Nausea and Vomiting Caused by Chemotherapy

Tue, 29 Jan 2008 20:35:55 GMT

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 29, 2008 - Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Emend (fosaprepitant dimeglumine) for Injection, a new intravenous therapy for...

Cangene's Recombinant Human Growth Hormone Accretropin Approved by the U.S. Food and Drug Administration

Fri, 25 Jan 2008 14:15:24 GMT

TORONTO and WINNIPEG, Jan. 24 /CNW/ - Cangene today announces that the U.S. Food and Drug Administration ("FDA") has approved Accretropin (somatropin (rDNA origin)) Injection, Cangene's recombinant human growth hormone ("rhGH"). The drug is...

ImaRx Therapeutics Receives Urokinase Lot Release Approval With Extended Expiration Dating

Fri, 25 Jan 2008 12:40:56 GMT

TUCSON, Ariz., Jan. 25 /PRNewswire-FirstCall/ -- ImaRx Therapeutics, Inc. today announced that the Food and Drug Administration (FDA) has approved the company's most current lot release request for urokinase drug product. This is the first...