New Delhi: Aurobindo Pharma Ltd 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 & Drug Administration (USFDA) to manufacture and market Famotidine Tablets,” Aurobindo Pharma said in a BSE filing.
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,” the company 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 USD 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.
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.