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Back To News: Omeprazole DR Caps Approval Granted
Omeprazole DR Caps Approval Granted
[Jul 05, 2017]

FOR IMMEDIATE RELEASE                                               

July 5, 2017 Ave., West Caldwell, NJ 07006 Contact us at


Breckenridge Announces Final Approval

for Omeprazole Delayed-Release Capsules


Boca Raton, Florida, July 5, 2017– 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.

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