Drug Development

Roxane Laboratories, Inc. Announces the Launch of Terbinafine Hydrochloride Tablets, 250mg

Published in Lab Business Week, July 22nd, 2007

Roxane Laboratories, Inc. announced that they received approval for its Abbreviated New Drug Application (ANDA) for Terbinafine Hydrochloride Tablets, 250mg by the U.S. Food and Drug Administration. The product is available in bottles of 30 tablets and 100 tablets for immediate shipment to wholesalers and pharmacies nationwide.

Roxane Laboratories' Terbinafine Hydrochloride Tablets, 250mg are AB rated to LAMISIL(R) (terbinafine hydrochloride). Annual sales of Terbinafine Hydrochloride Tablets, 250mg are approximately $687 Million(1).

Full prescribing information for Terbinafine Hydrochloride Tablets, 250mg is available on the Roxane Laboratories...

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Source: Lab Business Week (2007-07-22)

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