Aurobindo Pharma gets USFDA nod for two generic drugs

Aurobindo Pharma today announced receipt of final approval from the US health regulator to manufacture and market its generic versions of Parkinson's disease treatment drug Entacapone tablets and anti-biotics Azithromycin in the American market.
The approval by the US Food and Drug Administration (USFDA) to manufacture and market Entacapone Tablets is for strength of 200mg and product will be launched soon, the company said in a statement.
The tablets are generic versions of Orion Corporation's Comtan, used in the treatment of Parkinson's disease. As per IMS, the drug has an estimated market size of USD 59 million for the twelve months ending April 2015.

The approval for Azithromycin is for injection of 500mg per vial, which is generic equivalent of Pfizer's Zithromax injection, an antibacterial drug indicated for the treatment of patients with community-acquired pneumonia and pelvic inflammatory disease, the company said.
Shares of Aurobindo Pharma were trading at Rs 1,368.50 per scrip in the mid-day trade, up 0.71 per cent from the previous close on the BSE.