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Aurobindo Pharma gets USFDA nod for two drugs

IBEF:  April 28, 2016

New Delhi: The US Food & Drug Administration (USFDA) has granted approval to Aurobindo Pharma Limited, India's leading drug manufacturer, to manufacture and market heartburn relief medicine Famotidine tablets for strengths of 10 mg and 20 mg and Oxymorphone Hydrochloride Tablets for strengths of 5 mg and 10 mg. Both the products are expected to be launched in the Q2 of FY2016-17. According to data from IMS, Famotidine drug had an estimated market size of US$ 31 million in the 12 month period ended February 2016 whereas Oxymorphone Hydrochloride had a estimated market size of US$ 55.5 million for the same period. Aurobindo has a total of 257 Abbreviated New Drug Application (ANDA) approvals from the USFDA.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.