FDA nod for Aurobindo's acid reflux treatment drug
December 28, 2015 | Monday | News | By BioSpectrum Bureau
FDA nod for Aurobindo's acid reflux treatment drug
The approved ANDA is bioequivalent to Valeant Pharmaceuticals's Pepcid Tablets
Aurobindo Pharma announces that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 20 mg and 40 mg.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Pepcid Tablets, 20 mg and 40 mg, of Valeant Pharmaceuticals International.
Famotidine Tablets is used for the short-term treatment of gastroesophageal reflux disease and active duodenal ulcer. The approved product has an estimated market size of $29 million for the twelve months ending October 2015 according to IMS.
