Aurobindo gets FDA nod for acid reflux drug

Highlights

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

Hyderabad: City-based Aurobindo Pharma on Thursday said it had 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 & Drug Administration (USFDA) to manufacture and market Famotidine Tablets," the company said in a statement. Approval has been granted for Famotidine Tablets of 20 mg and 40 mg strengths.

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, it added. Famotidine Tablets is 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 for the twelve 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.

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