Mylan, Barr get final FDA approval for Zonisamide, generic of Zonegran to treat epilepsy

By E. Janene Geiss

Philadelphia, Dec. 23 - The Food and Drug Administration has given final approval to Mylan Laboratories Inc.'s and Barr Pharmaceuticals, Inc.'s Abbreviated New Drug Applications for Zonisamide capsules, 25 mg, 50 mg and 100 mg.

Both companies said they would begin shipping the AB-rated generic equivalent of Zonegran immediately.

The brand name, made by Dainippon Pharmaceutical, has U.S. sales of about $171 million in 2005, according to IMS Health.

Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

Mylan is a Pittsburgh-based pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc., which develop, license, manufacture, market and distribute generic and proprietary products.

Barr is a Woodcliff, N.J., holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.

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