First-Time Generic Approvals: Ambien, Zoloft, Nimotop

May 04, 2007

May 4, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for zolpidem tartrate 5-mg and 10-mg tablets for treatment of insomnia; sertraline hydrochloride tablets 150 mg and 200 mg for treatment of depression; and nimodipine 30-mg soft gelatin capsules for improved neurological outcome following subarachnoid hemorrhage.

Generic Zolpidem Tartrae (Ambien) for Insomnia

On April 23, the FDA approved the first generic formulation of zolpidem tartrate 5-mg and 10-mg immediate-release tablets for treatment of insomnia (brand name Ambien, sanofi-aventis). Thirteen manufacturers have received FDA approval for zolpidem tartrate tablets, including Mylan Pharmaceuticals Inc., TEVA Pharmaceuticals USA, Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy’s Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc., Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.

Zolpidem tartrate belongs to the sedative-hypnotic class of drugs, and is indicated for the short-term treatment of insomnia. In March of this year, the FDA requested that manufacturers of sedative-hypnotic drugs include stronger language on product labeling with regard to potential risks, such as severe allergic reactions or complex sleep-related behaviors. This request will also apply to generic versions of these drugs.

The approval for the generic formulation of zolpidem tartrate follows the expiration of the sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent on April 21, 2007.

Generic Sertraline Hydrochloride (Zoloft ) for Depression

On February 6, the FDA approved the first generic formulation of sertraline hydrochloride tablets 150 mg and 200 mg (Ranbaxy Laboratories Limited; brand name Zoloft, Pfizer Pharmaceuticals, Inc.) for treatment of depression in adults.

Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI), a class of drugs used to treat depressive symptoms such as sadness or irritability. The FDA approval for Ranbaxy also included generic formulation of sertraline hydrochloride tablets in 25-mg, 50-mg, and 100-mg strengths. Pfizer Pharmaceuticals no longer markets Zoloft in 150-mg or 200-mg strengths.

Generic Nimodipine (Nimotop) for Neurological Deficits Caused by Cerebral Vasospasm

On April 17, the FDA approved the first generic formulation of nimodipine 30-mg soft gelatin capsules (Sun Pharmaceutical Industries, Inc; brand name Nimotop, Bayer Pharmaceuticals) for improved neurological outcome following subarachnoid hemorrhage (SAH).

Nimodipine belongs to a class of drugs known as calcium channel blockers, and relaxes vascular smooth muscle tone by slowing or preventing the movement of calcium into the cells.

On behalf of Sun Phamaceuticals, nimodipine capsules will be marketed by Caraco Pharmaceutical Laboratories, Ltd.

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