Breckenridge Announces Approval of Terbinafine HCl Tablets

Thursday, June 10, 2010 Drug News J E 4

BOCA RATON, Fla., June 9 Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Terbinafine HCl Tablets, 250mg. Terbinafine HCl Tablets are AB rated to LamisilŪ, a brand product marketed by Novartis. Breckenridge plans to launch the product this summer.

About Breckenridge:

Breckenridge Pharmaceutical is a privately held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of Generic prescription products in many therapeutic categories; including several unique ValuBrand(TM) products. The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide. The company markets multiple ANDA's, in a variety of dosage forms including: Tablets, Capsules, Soft Gel Capsules, Liquids, and Powders. Breckenridge was recently honored as a 50th Anniversary DIANA award winner for "Best Overall Generic Products Manufacturer" by the HDMA in October 2009.

SOURCE Breckenridge Pharmaceutical, Inc.


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