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Aurobindo Pharma Ltd has received approval from the US Food and Drug Administration (USFDA) for acetylcysteine injection.
The product is expected to be launched in the first quarter of 2016-17, the Hyderabad-based company said in a release issued here on Tuesday.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Acetadote of Cumberland Pharmaceuticals Inc and is indicated to prevent or lessen hepatic injury.
The approved product has an estimated market size of $28 million for the 12 months ended December 2015, according to IMS.
The company’s scrip gained 1.73 per cent on the Bombay Stock Exchange on Tuesday and is trading at Rs 666.50.
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