Aurobindo Pharma receives USFDA Approvals for Oxymorphone Hydrochloride Tablets & Famotidine Tablets (OTC).

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Oxymorphone Hydrochloride Tablets, 5 mg and 10 mg.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Opana® (oxymorphone hydrochloride) Tablets, 5 mg and 10 mg, of Endo Pharmaceuticals, Inc.

Oxymorphone Hydrochloride Tablets is used to help relieve moderate to severe acute pain where the use of an opioid is appropriate.

The approved product has an estimated market size of US$ 55.5 million for the twelve months ending February 2016 according to IMS.

This is the 11th ANDA to be approved out of Aurolife formulation facility in New Jersey, USA for manufacturing Non-Antibiotic products & Controlled substances.

Aurobindo Pharma Limited has also received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 10 mg and 20 mg (OTC).

This product is expected to be launched in Q2 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Pepcid® AC Tablets, 10 mg and 20 mg, of McNeil Consumer Pharmaceuticals Co.

Famotidine Tablets (OTC) is used to relieve heartburn associated with acid indigestion and sour stomach.

The approved product has an estimated market size of US$ 31 million for the twelve months ending February 2016 according to IMS.

Aurobindo now has a total of 257 ANDA approvals (220 Final approvals including 11 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.

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