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Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Linezolid injection.
The injection is an anti-infective and is used to treat infections caused by susceptibl gram-positive bacteria in specific conditions, the Hyderabad-based company said in a release issued here on Monday.
The approved Abbreviated New Drug Application (ANDA) is a bio-equivalent and is therapeutically equivalent to reference listed drug product Zyvox injection of Pharmacia & Upjohn Company.
The product, which is expected to be launched in the current quarter, has an estimated market size of $87 million for the 12 months ending June 2016, according to IMS.
Aurobindo’s scrip gained 0.63 per cent and was trading at Rs 774.95 on the BSE on Monday.
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