Breckenridge Announces Tentative Approval for Dutasteride Soft Gelatin Capsules

BOCA RATON, Fla., Sept. 11, 2015 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today receipt of tentative ANDA approval of Dutasteride Soft Gelatin Capsules 0.5mg, which is AB rated to Avodart®, a drug marketed by GlaxoSmith Kline. Avodart® annual sales totaled $467 million based on IMS Health sales data.  Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.  Breckenridge intends to launch its ANDA on November 20, 2015, upon the expiration of U.S. patent 5,565,467.

About Breckenridge: 
Breckenridge Pharmaceutical, Inc. 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. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 70 products in a variety of dosage forms including: tablets, capsules, soft gel capsules, liquids, suspensions, ophthalmics, nasal sprays and powders. www.bpirx.com

* The brands listed are trademarks of their respective owners.  

SOURCE Breckenridge Pharmaceutical, Inc.

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