Drugs.com - New Drug Approvals

Prism Pharmaceuticals Receives FDA Approval of Nexterone for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia

Mon, 05 Jan 2009 14:35:43 GMT

KING OF PRUSSIA, Pa., January 05, 2009 /PRNewswire/ -- Prism Pharmaceuticals announced today that the U.S. Food & Drug Administration (FDA) has approved the new drug application (NDA) for Nexterone (amiodarone HCl) Injection, a novel,...

Labopharm Announces FDA Approval of Once-Daily Ryzolt for Moderate to Moderately Severe Chronic Pain

Wed, 31 Dec 2008 12:10:50 GMT

December 31, 2008 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that Ryzolt (tramadol HCl extended release tablets), Labopharm's once-daily formulation of the analgesic tramadol, has been approved by the U.S. Food and Drug Administration...

Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse -- First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes

Mon, 29 Dec 2008 18:34:25 GMT

IRVINE, Calif.--(BUSINESS WIRE)--Dec 26, 2008 - Allergan, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Latisse (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash...

FDA Approves Ferring Pharmaceuticals' Degarelix for Treatment of Advanced Prostate Cancer

Mon, 29 Dec 2008 18:34:01 GMT

PARSIPPANY, N.J., December 24, 2008 /PRNewswire/ -- Ferring Pharmaceuticals, USA today received approval from the U.S. Food and Drug Administration (FDA) for degarelix, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist,...

EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium)

Mon, 22 Dec 2008 20:20:46 GMT

First Imaging Agent Approved for Magnetic Resonance Angiography (MRA) in the U.S. LEXINGTON, Mass.--(BUSINESS WIRE)--Dec 22, 2008 - EPIX Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing novel therapeutics...

NovaDel Pharma Receives FDA Approval of Zolpimist

Mon, 22 Dec 2008 13:39:21 GMT

FLEMINGTON, N.J.--(BUSINESS WIRE)--Dec 22, 2008 - NovaDel Pharma Inc. today announced that Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray has been approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of...

FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

Mon, 22 Dec 2008 11:58:36 GMT

ROCKVILLE, Md., Dec. 19, 2008--The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or...

Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote

Fri, 19 Dec 2008 14:25:44 GMT

Revised label includes additional safety data from more than 6,500 patients NASHVILLE, Tenn., December 18, 2008 /PRNewswire/ -- Cumberland Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved updated...

Antisoma Receives FDA Approval for Oral Fludarabine, Plans Commercialization Deal to Bring Drug to US Patients

Fri, 19 Dec 2008 13:40:04 GMT

LONDON, and CAMBRIDGE, MA, 19 December 2008 – Antisoma plc today announced that the United States Food and Drug Administration (FDA) has approved its tablet formulation of fludarabine phosphate ('oral fludarabine') as a second-line treatment for...

Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application

Fri, 19 Dec 2008 12:47:19 GMT

Reduced Dosage and Intramuscular Administration Approved ROCKVILLE, Md.--(BUSINESS WIRE)--Dec 19, 2008 - Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Emergent's supplemental Biologics...

FDA Approves Genzyme's Mozobil

Tue, 16 Dec 2008 12:27:17 GMT

Product provides enhanced mobilization of stem cells for autologous transplantation in Non-Hodgkin's Lymphoma and Multiple Myeloma patients CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 15, 2008 - Genzyme Corporation announced today that the U.S. Food and...

Abbott Receives FDA Approval for Trilipix (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management

Mon, 15 Dec 2008 21:38:51 GMT

New Therapy in Combination with a Statin Helped Patients Improve HDL and LDL Cholesterol and Triglycerides in Clinical Studies ABBOTT PARK, Ill., December 15, 2008 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA)...

FDA Approves Lusedra (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation

Mon, 15 Dec 2008 13:31:20 GMT

WOODCLIFF LAKE, N.J., Dec. 14 /PRNewswire/ -- Eisai Corporation of North America today announced that the U.S. Food and Drug Administration (FDA) has approved Lusedra (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for...

FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough Vaccine, Boostrix, for Adults

Sat, 13 Dec 2008 05:00:00 GMT

New Indication for Booster Vaccine Expands Disease Protection to Individuals Aged 10-64 Years PHILADELPHIA, PA--(Marketwire - December 8, 2008) - GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved Boostrix...

Schering-Plough Announces FDA Approval of PegIntron and Rebetol Combination Therapy for Treating Pediatric Hepatitis C

Fri, 12 Dec 2008 16:05:02 GMT

First and only approved peginterferon in combination with ribavirin for previously untreated children with chronic hepatitis C addresses unmet medical need KENILWORTH, N.J., December 12, 2008 /PRNewswire-FirstCall/ -- Schering-Plough Corporation...

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...