Generic Drug Approvals

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Generic Drug Approvals

First-Time Generic Approvals: Copegus, Tegretol, Roxicodone

Yael Waknine;

Jan. 24, 2006 — The US Food and Drug Administration (FDA) approved in December 2005 first-time generic 200-mg formulations of ribavirin and carbamazepine tablets, and 15- and 30-mg formulations of oxycodone HCl tablets. First-time doses (ie, no brand equivalent) have also been approved in generic formulations for carbamazepine 100-, 300-, and 400-mg tablets, and oxycodone 5-, 10-, and 20-mg tablets.Generic Ribavirin (Copegus) for HCV Combination TherapyOn December 5, the FDA approved a first-time generic 200-mg formulation of ribavirin tablets (made by Three Rivers Pharmaceuticals LLC, Zydus Pharmaceuticals USA Inc, and Teva Pharmaceuticals Inc; brand name Copegus, made by Roche Laboratories Inc).Ribavirin tablets are indicated for use with peginterferon alfa-2a in the treatment of adults with chronic hepatitis C virus (HCV) infection who have compensated disease and who have not previously been treated with interferon alfa.New Generic Doses of Carbamazepine (Tegretol) for Seizures and Trigeminal Neuralgia On December 7, the FDA approved a first-time generic 200-mg formulation of carbamazepine tablets and first-time generic 100-, 300-, and 400-mg doses of carbamazepine tablets (made by Caraco Pharmaceutical Laboratories Ltd; brand name Tegretol 200-mg tablets, made by Novartis Pharmaceuticals Corporation).Carbamazepine tablets are indicated for the treatment of partial seizures with complex symptomology, generalized tonic-clonic seizures, and other mixed seizure patterns. They are also indicated for the treatment of pain associated with trigeminal neuralgia.New Generic Doses of Oxycodone HCl (Roxicodone) for Moderate to Severe PainOn December 8, the FDA approved first-time generic 15- and 30-mg formulations of immediate-release oxycodone HCl tablets, and first-time generic 5-, 10-, and 20-mg doses of oxycodone tablets (made by KV Pharmaceutical Company; brand name Roxicodone, made by Roxane Laboratories, Inc). Immediate-release oxycodone tablets are indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. Reviewed by D. Vogin, MD

http://www.medscape.com/viewarticle/522187