Aurobindo Pharma gets USFDA nod for acid reflux treatment medicine

Aurobindo Pharma on Thursday said it has received final approval from the US health regulator to manufacture and market Famotidine Tablets used for acid reflux treatment.

"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Famotidine Tablets," Aurobindo Pharma said in a BSE filing.

The approval has been granted for Famotidine Tablets of 20 milligram (mg) and 40 mg strengths.

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"The approved ANDA (Abbreviated New Drug Application) is bioequivalent and therapeutically equivalent to the reference listed drug product Pepcid Tablets, 20 mg and 40 mg, of Valeant Pharmaceuticals International, Inc," the company added.

Famotidine tablets are used for the short-term treatment of gastroesophageal reflux disease and active duodenal ulcer.

Quoting IMS data, Aurobindo Pharma said the approved product had an estimated market size of $29 million (nearly Rs 192.10 crore) for the 12 months ending October 2015.

This is the 54th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India, for manufacturing Oral Non-Antibiotic products, the company said.

Aurobindo now has a total of 226 ANDA approvals (198 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from the USFDA.

At 1246 hours, the shares of Aurobindo Pharma  were trading up 0.89% or Rs 7.70 at Rs 876.35 per scrip intraday on BSE.