Aurobindo Pharma receives USFDA approval

 The Dollar Business Bureau

Aurobindo Pharma, a Hyderabad-based company, has announced that it has finally received approval to manufacture and market Oxymorphone Hydrochloride and Famotidine tablets from the United States Food and Drug Administration (USFDA). The approved Abbreviated New Drug Application (ANDA) is bio and therapeutic equivalent to listed drug under Reference Listed Drug (RLD).

Manufactured by Endo Pharmaceuticals, Inc., Oxymorphone Hydrochloride is a pain relief drug for moderate to acute pain, wherever the prescription of Opioid is appropriate. As approved by ANDA, dosages must be 5mg and 10mg. According to IMS Health, the product has a market size of $55.5 million for a period of 12-months, ending February 2016.

While, Famotidine tablets (ANDA approved dosages for this drug is 10mg and 20mg), manufactured by McNeil Consumer Pharmaceuticals Company are for heartburn relief. Its market size is roughly $31 million for a period of 12-month, ending February 2016, as estimated by IMS Health.

The products are expected to launch in the second quarter of FY2017. Aurobindo Pharma has a total of 257 ANDA approvals from the USFDA, out of which of which 220 drugs have received their final approval, while 37 drugs are tentatively approved.