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Aurobindo Pharma Ltd has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Entacapone tablets.
The product will be launched soon, the Hyderabad-based company said in a release issued here on Monday. .
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Comtan tablets of Orion Corporation. Entacapone tablets are used in the treatment of Parkinson's disease and has an estimated market size of $59 million for the 12 months ended April30, 2015, according to IMS.
Aurobindo has also received US regulator’s nod to manufacture and market Azithromycin for injection. It is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zithromax (Azithromycin for Injection) of Pfizer, Inc.
It is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions such as Community-Acquired Pneumonia and Pelvic Inflammatory Disease.
The company’s scrip gained 0.74 per cent to Rs 1,369 on the BSE.
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