Breckenridge Announces Final Approval for Dutasteride Soft Gelatin Capsules

News provided by

Nov 20, 2015, 11:15 ET

BOCA RATON, Fla., Nov. 20, 2015 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for 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 recent IMS Health sales data. Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Breckenridge will launch the product immediately.

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.