Drugs.com - New Drug Approvals

FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream

Mon, 01 Dec 2008 19:25:21 GMT

MONTVALE, N.J., December 01, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for...

Pfizer's Novel HIV/AIDS Treatment Selzentry Becomes the Latest Fully Approved Antiretrovial for Treatment-Experienced HIV Patients

Wed, 26 Nov 2008 14:20:21 GMT

NEW YORK--(BUSINESS WIRE)--Nov 25, 2008 - The U.S. Food and Drug Administration (FDA) has granted Selzentry (maraviroc) full (traditional) approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other...

FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain

Fri, 21 Nov 2008 21:15:03 GMT

RARITAN, N.J., November 21, 2008 /PRNewswire/ -- Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Today, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.,...

FDA Approves Promacta (eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder

Fri, 21 Nov 2008 13:40:24 GMT

PHILADELPHIA, November 20, 2008 /PRNewswire-FirstCall/ --GlaxoSmithKline today announced that the United States Food and Drug Administration (FDA) granted accelerated approval for Promacta (eltrombopag) for the treatment of thrombocytopenia in...

FDA Responds to AstraZeneca’s Citizen Petition -- FDA Also Grants Approval for a Generic Version of Pulmicort Respules

Wed, 19 Nov 2008 14:10:42 GMT

LONDON, Nov. 19, 2008-On 18 November 2008, the US FDA responded to AstraZeneca's Citizen Petition surrounding the company's concern about the approval of any generic version of Pulmicort Respules (budesonide inhalation suspension). While the FDA...

FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder

Mon, 17 Nov 2008 13:50:26 GMT

WOODCLIFF LAKE, N.J., November 14, 2008/PRNewswire/ --Eisai Corporation of North America announced today that the U.S. Food and Drug Administration (FDA) approved Banzel (rufinamide) for the adjunctive treatment of seizures associated with...

FDA Approves Low-dose Regimen of Premarin Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse

Thu, 13 Nov 2008 16:15:43 GMT

COLLEGEVILLE, Pa., Nov. 13 /PRNewswire-FirstCall/ -- Premarin (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to...

FDA Approves 30-Minute Onset of Action for Focalin XR

Wed, 12 Nov 2008 16:00:57 GMT

Data indicate Focalin XR provides rapid and significant improvements in attention, behavior and academic productivity at 30 minutes post-dose EAST HANOVER, N.J., November 12, 2008 /PRNewswire/ -- The US Food and Drug Administration (FDA) has...

EKR Therapeutics Broadens Its Ready-to-Use Cardene I.V. Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags

Tue, 11 Nov 2008 20:50:04 GMT

BEDMINSTER, N.J.--(BUSINESS WIRE)--Nov 11, 2008 - EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received approval from the U.S. Food and...

FDA Approves Ranexa for First Line Anti Anginal Use

Thu, 06 Nov 2008 13:25:02 GMT

PALO ALTO, Calif., Nov. 6 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa (ranolazine extended-release tablets) for the treatment...

Crestor Approved for Primary Dysbetalipoproteinemia

Thu, 06 Nov 2008 05:00:00 GMT

November 6, 2008 - The United States Food and Drug Administration has approved an additional indication for Crestor. Crestor is now approved for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III...

FDA Approves Additional Indication for Norditropin for Small for Gestational Age (SGA) in Children

Tue, 04 Nov 2008 16:10:06 GMT

PRINCETON, N.J., November 04, 2008 /PRNewswire-FirstCall/ --Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin (somatropin [rDNA origin]...

Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

Mon, 03 Nov 2008 13:30:41 GMT

FRAZER, Pa., Oct. 31, 2008 /PRNewswire-FirstCall/ -- Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Treanda (bendamustine hydrochloride) for Injection for the treatment of patients with indolent B-cell...

Apriso Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis

Mon, 03 Nov 2008 13:20:23 GMT

RALEIGH, N.C.--(BUSINESS WIRE)--Oct 31, 2008 - Salix Pharmaceuticals, Ltd. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Apriso (mesalamine) extended-release capsules 0.375 g. Apriso is a...

Pfizer's Toviaz (fesoterodine fumarate) Receives FDA Approval for the Treatment of Overactive Bladder

Fri, 31 Oct 2008 18:55:07 GMT

NEW YORK--(BUSINESS WIRE)--Oct 31, 2008 - Pfizer Inc said today that the U.S. Food and Drug Administration (FDA) approved Toviaz (fesoterodine fumarate) extended release tablets for the treatment of overactive bladder (OAB) symptoms. New once-daily...

FDA Approves New Indication for Hospira's Precedex (dexmedetomidine HCl) Injection

Thu, 30 Oct 2008 15:45:26 GMT

LAKE FOREST, Ill., October 30, 2008 /PRNewswire-FirstCall/ -- Hospira, Inc. , a global specialty pharmaceutical and medication delivery company, announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for Precedex,...

UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy for Partial Onset Seizures in Adults

Wed, 29 Oct 2008 16:35:29 GMT

BRUSSELS, October 29, 2008 - UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Vimpat (lacosamide), a new antiepileptic drug (AED). Vimpat is for use as an add-on therapy for the treatment of partial-onset seizures in...

FDA Approves Rapid-Acting Insulin Apidra for Treatment of Children with Diabetes

Wed, 29 Oct 2008 14:55:17 GMT

BRIDGEWATER, N.J., October 29, 2008 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra (insulin glulisine [rDNA origin] injection) to improve glycemic control in children (4...

Novartis Secures Two FDA Approvals for Parkinson's Drug Stalevo

Wed, 29 Oct 2008 13:15:38 GMT

Two new dosage strengths of Stalevo approved in the U.S. provide greater dosing flexibility for people with Parkinson’s disease • New dosage strengths offer physicians more options to tailor treatment approaches for patients, and may lessen the...

FDA Approves Duramed's LoSeasonique Oral Contraceptive

Mon, 27 Oct 2008 14:55:28 GMT

MONTVALE, N.J., October 27, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for...

FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia

Wed, 22 Oct 2008 15:15:42 GMT

DEERFIELD, Ill., October 22, 2008 /PRNewswire/ -- Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new premixed formulation of Vaprisol: Vaprisol (conivaptan hydrochloride injection) Premixed...

U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1

Wed, 22 Oct 2008 12:50:52 GMT

BRIDGEWATER, N.J., October 22, 2008 /PRNewswire/ -- The FDA has granted Prezista (darunavir) tablets, a protease inhibitor, approval for an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults (those...

FDA Approves Acanya

Tue, 21 Oct 2008 04:00:00 GMT

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Nov 20, 2008 - Arcutis Pharmaceuticals, a privately held specialty pharmaceutical organization focusing in medical dermatology, announced today that the United States Food and Drug Administration (FDA) has...

FDA Approves Astepro

Fri, 17 Oct 2008 13:25:56 GMT

STOCKHOLM, Sweden--(BUSINESS WIRE)--Oct 17, 2008 - The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated...

Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks

Mon, 13 Oct 2008 13:10:50 GMT

NEW YORK--(BUSINESS WIRE)--Oct. 10, 2008 - Lev Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cinryze (C1 inhibitor (human)) for routine prophylaxis against angioedema attacks in adolescent and adult...

FDA Approves Bayer HealthCare's Kogenate FS Treatment for Routine Prophylaxis in Children with Hemophilia A

Fri, 10 Oct 2008 19:10:35 GMT

BERKELEY, Calif., October 10, 2008 /PRNewswire/ -- Bayer HealthCare LLC announced today that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate FS Antihemophilic Factor (Recombinant) to reduce the frequency of...

FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US

Fri, 10 Oct 2008 13:15:56 GMT

LONDON, Oct. 10, 2008--AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Seroquel XR (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with...

FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment

Fri, 10 Oct 2008 11:40:17 GMT

TITUSVILLE, N.J., October 09, 2008 /PRNewswire-FirstCall/Patients with schizophrenia now have a new administration option for Risperdal Consta ([risperidone] Long-Acting Injection). The U.S. Food and Drug Administration (FDA) has approved a new...

Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)

Thu, 09 Oct 2008 12:05:47 GMT

CORONA, Calif., October 08, 2008 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Rapaflo (silodosin), the company's new...

Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5%

Wed, 08 Oct 2008 12:50:17 GMT

LAKE FOREST, Ill.--(BUSINESS WIRE)--Oct. 8, 2008 - Akorn, Inc. (NASDAQ: AKRX) today announced the FDA approval of NDA 22-221 for Akten Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation. The NDA was filed June 29, 2007 following the...

U.S. Food & Drug Administration Approved the use of Reyataz (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients

Thu, 02 Oct 2008 16:41:00 GMT

PRINCETON, N.J., Oct. 1, 2008-- BUSINESS WIRE --Bristol-Myers Squibb Company announced today that the U.S. Food & Drug Administration (FDA) approved the use of Reyataz (atazanavir sulfate) 300 mg once-daily boosted with ritonavir 100 mg as part of...

FDA Grants Lilly's Alimta (Pemetrexed for Injection) Third U.S. Approval

Mon, 29 Sep 2008 15:00:06 GMT

INDIANAPOLIS, Sept. 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company announced today it received approval from the U.S. Food and Drug Administration (FDA) for the use of Alimta (pemetrexed for injection), in combination with cisplatin, in the...

Boston Scientific Announces FDA Approval of TAXUS Express2 Atom Stent System, First Drug-Eluting Stent For Small Vessels

Thu, 25 Sep 2008 13:25:29 GMT

Company also announces FDA approval of TAXUS Express2 Stent System for treatment of in-stent restenosis NATICK, Mass., September 25, 2008 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced that it has received approval from the...

Teva's ProAir HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication

Wed, 24 Sep 2008 13:05:48 GMT

JERUSALEM--(BUSINESS WIRE)--Sept. 23, 2008 - Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved ProAir HFA (albuterol sulfate) Inhalation Aerosol for use in patients as young as 4 years...

FDA Approves Nasacort AQ Nasal Spray for Children Aged 2-5 years old

Tue, 23 Sep 2008 12:20:35 GMT

BRIDGEWATER, N.J., September 23, 2008 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today the U.S. Food and Drug Administration (FDA) has approved Nasacort AQ Nasal Spray (triamcinolone acetonide) for children aged 2-5 years old for the...

FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults

Fri, 19 Sep 2008 19:40:11 GMT

PRINCETON, N.J.--(BUSINESS WIRE)--Sep 19, 2008 - GE Healthcare, a unit of General Electric Company (NYSE:GE), today announced that the Food and Drug Administration (FDA) has approved AdreView (Iobenguane I 123 Injection), a molecular imaging agent...

FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States

Mon, 15 Sep 2008 15:16:00 GMT

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Sept. 15, 2008 - Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted approval for Gamunex (Immune Globulin Intravenous (Human), 10%...

Keppra XR Approved in the U.S.

Mon, 15 Sep 2008 13:55:02 GMT

Brussels, BELGIUM - September 15, 2008 - UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra XR (levetiracetam extended-release tablets) for use as an add-on to other antiepileptic treatments for people with...

FDA Approves Sancuso, the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy

Mon, 15 Sep 2008 13:25:29 GMT

BEDMINSTER, N.J., September 15, 2008 /PRNewswire-FirstCall/ -- ProStrakan Group plc today announced the U.S. Food and Drug Administration (FDA) approval of Sancuso (granisetron transdermal system), the first and only patch to provide up to five...

FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

Mon, 15 Sep 2008 12:10:42 GMT

ROCKVILLE, Md., Sept. 12, 2008--The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9...