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The Latest FDA Approved Generic Medication and New Pharmaceuticals
PRESTIGE® Cervical Disc System
Published by admin | Filed under Medical Device
Medtronic Receives Approval for First Artificial Disc for the Neck in the United States MEMPHIS, Tenn. – July 16, 2007 – Medtronic, Inc. (NYSE: MDT) announced today that it has received U.S. Food and Drug Administration (FDA) approval to market the PRESTIGE® Cervical Disc, the first artificial disc commercially available in the U.S. for use [...]
Generic Toradol: Akorn-Strides Ketorolac Tromethamine
Published by admin | Filed under Generic Drugs
Akorn-Strides, LLC Announces its First ANDA Approval For Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL Tuesday, July 17, 2007 BUFFALO GROVE, Ill. - Akorn-Strides, LLC today announced its first ANDA approval for Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, [...]
FDA Approves CustomVue Monovision LASIK
Published by admin | Filed under Procedures
The U.S. Food and Drug Administration approved for marketing the first LASIK device designed for treating one eye to see far away objects and the other eye for close-up vision. “The approval of the CustomVue Monovision LASIK expands permanent vision correction options for nearsighted adults who also have trouble focusing on objects close-up,” said Daniel [...]
Generic Tenormin: ATENOLOL by CARACO
Published by admin | Filed under Generic Drugs
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Tenormin(R) DETROIT, July 11 - Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for Atenolol Tablets USP (atenolol). Atenolol is indicated in the management [...]
Generic NORVASC: AMLODIPINE BESYLATE by ROXANE LABORATORIES
Published by admin | Filed under Generic Drugs
ROXANE LABORATORIES, INC. ANNOUNCES THE LAUNCH OF AMLODIPINE BESYLATE TABLETS, 2.5MG, 5MG, 10MG COLUMBUS, OH – July 9, 2007 – Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg by the U.S. Food and Drug Administration. The product is available in bottles [...]
Generic Lioresal: BACLOFEN by LANNETT
Published by admin | Filed under Generic Drugs
Lannett Receives Approval to Market Baclofen 10mg Tablets 07/12/07 – PHILADELPHIA -Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Baclofen 10mg tablets, bolstering the company’s existing product offering of Baclofen 20mg [...]
FDA approves EXELON PATCH from NOVARTIS
Published by admin | Filed under New Drugs
Exelon®Patch, the first and only skin patch for the treatment of Alzheimer’s disease, receives first worldwide approval in US Once-daily skin patch offers novel approach to treating mild to moderate Alzheimer’s disease, providing smooth and continuous delivery of drug over 24 hours Similar efficacy to highest doses of Exelon capsules with significant improvement in memory [...]
Generic Dostinex and Cabaser: CABERGOLINE by BARR
Published by admin | Filed under Generic Drugs
Barr Announces Approval of Generic Dostinex(R) WOODCLIFF LAKE, N.J., July 9, 2007 — Barr Pharmaceuticals, Inc. today announced that its subsidiary Barr Laboratories, Inc. has received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Pharmacia and Upjohn Company’s Dostinex(R) (cabergoline) tablets, 0.5 mg. The [...]
Generic Lamisil: TERBINAFINE HYDROCHLORIDE by TEVA
Published by admin | Filed under Generic Drugs
Teva Announces Approval Of Terbinafine Hcl Tablets Jerusalem, Israel, July 3, 2007 – Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company’s Abbreviated New Drug Application(ANDA) to market Terbinafine Hydrochloride Tablets, 250 mg (base), the AB-rated generic equivalent of Novartis’ antifungal [...]