Le Lézard
Classified in: Health
Subject: FDA

Breckenridge Announces Final Approval for Omeprazole Delayed-Release Capsules



BOCA RATON, Fla., July 5, 2017 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today it has received U.S. Food and Drug Administration final approval of its abbreviated new drug application (ANDA) for Omeprazole delayed-release capsules, USP, in 10mg, 20mg, 40mg strengths (AB rated to Prilosec®), which will be manufactured and supplied by its parent company, Laboratorios Dr. Esteve, S.A. (Barcelona, Spain).  This ANDA is part of Breckenridge's growing portfolio of vertically-integrated products with Esteve, with the product's API manufactured by Esteve's API division, Esteve Quimica.  Launch plans currently are underway.

Omeprazole Delayed-release Capsules is a proton pump inhibitor (PPI) used to treat certain stomach and esophagus issues such as GERD and ulcers.  The total combined sales for this market is $266,847,966 for the 12-month period ending April 2017, based on industry data.

About Breckenridge:
Breckenridge Pharmaceutical, Inc. is a privately-held own label Distributor that performs pharmaceutical research and development as well as marketing and distribution in the U.S. The company was founded in 1983 and 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, powders and injectables, with 39 Paragraph IV challenges filed to date. www.bpirx.com

Prilosec® is a registered trademark of AstraZeneca

SOURCE Breckenridge Pharmaceutical, Inc.


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