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Aurobindo receives FDA approval for famotidine tablets

12/28/2015

DAYTON, N.J. — Aurobindo announced last week that the Food and Drug Administration approved its famotidine tablets in the 20 mg and 40 mg strengths to treat gastroesophageal reflux diesease and active duodenal ulcer.


The approved ANDA is bioequivalent and therapeutically equivalent to Pepcid tablets, 20 mg and 40 mg, from Valeant Pharmaceuticals.


Famotidine tablets have an estimated market size of $29 million for the 12 months ended October 2015, according to IMS.


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