Aurobindo Pharma on Wednesday said it has received final approval from the US health regulator to manufacture and market generic version of heartburn relief medicine Famotidine tablets.
The approval by the US Food and Drug Administration (USFDA) is for strengths of 10 mg and 20 mg, the company said in a BSE filing. This product is expected to be launched in the second quarter of 2016-17, it added. The drug is bio-equivalent and therapeutically equivalent to the reference listed product Pepcid AC Tablets -- 10 mg and 20 mg -- of McNeil Consumer Pharmaceuticals Co, it said.
Citing IMS data, the company said that the approved product had an estimated market size of $31 million in the 12 month period ended February 2016. It also got final nod from the USFDA to make and market pain relief drug Oxymorphone Hydrochloride tablets in the strengths of 5 mg and 10 mg. “The approved ANDA is bio-equivalent and therapeutically equivalent to the reference listed drug product Opana (Oxymorphone Hydrochloride) tablets, 5 mg and 10 mg, of Endo Pharmaceuticals, Inc,” it added.