First-Time Generic Approvals: Seasonale, Imodium Advanced, and Topamax

Yael Waknine

September 22, 2006

September 22, 2006 — The US Food and Drug Administration (FDA) has approved first-time generic formulations of ciprofloxacin levonorgestrel plus ethinyl estradiol 0.15-mg/0.03-mg tablets for contraceptive use; nonprescription loperamide HCl plus simethicone 2-mg/125-mg tablets for controlling symptoms of diarrhea and gas; and topiramate 25-, 100-, and 200-mg tablets for the treatment of epilepsy and the prevention of migraines.


Generic Levonorgestrel Plus Ethinyl Estradiol Tablets (Seasonale) for Contraceptive Use


On September 6, the FDA approved a generic formulation for levonorgestrel plus ethinyl estradiol
0.15-mg/0.03-mg tablets ( Quasense, made by Watson Laboratories, Inc; brand name Seasonale, made by Duramed Pharmaceuticals, Inc, a subsidiary of Barr Pharmaceuticals, Inc).

According to a company news release, the product will be launched immediately in the US market. A second generic version of the drug is also expected to be marketed by the Barr Labs unit of Barr Pharma under the trade name Jolessa
.

Levonorgestrel/ethinyl estradiol is indicated for contraceptive use in women. The extended-cycle regimen consists of 84 active pills followed by 7 placebo tablets, thereby reducing the incidence of menstrual periods from 13 to 4 per year.


Generic Loperamide HCl Plus Simethicone Tablets (Imodium Advanced) for Lower GI Symptoms


On September 6, the FDA approved a generic formulation for nonprescription loperamide HCl plus simethicone 2-mg/125-mg tablets (made by Ranbaxy Laboratories Ltd; brand name Imodium Advance Caplets
, made by McNeil Consumer and Specialty Pharmaceuticals, a division of McNeil PPC, Inc).

Loperamide plus simethicone over-the-counter tablets are indicated for controlling symptoms of diarrhea
plus bloating, pressure, and cramps commonly referred to as gas.


Generic Topiramate Tablets (Topamax) for Epilepsy Therapy, Migraine Prophylaxis


On September 11, the FDA approved first-time 25-, 100-, and 200-mg tablet generic formulations for topiramate (made by Mylan Laboratories, Inc; brand name Topamax
, made by Ortho-McNeil Pharmaceutical, Inc, a Johnson & Johnson company). A 50-mg strength was granted tentative approval only.

Topiramate is indicated as initial monotherapy for partial onset or primary generalized tonic-clonic seizures
in patients aged 10 years and older, as adjunctive therapy for pediatric patients aged 2 to 16 years and for adults with partial onset seizures or primary generalized tonic-clonic seizures, adjunctive therapy for seizures associated with Lennox-Gastaut syndrome
in patients aged 2 years and older, and for the prophylaxis of migraine headache
in adults.

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