FDA okays Glenmark’s drug application

FDA okays Glenmark’s drug application

Mumbai: Shares of drug maker Glenmark Pharmaceuticals Ltd on Wednesday rose 1.58% on the Bombay Stock Exchange to close at Rs266.25 after the company announced that its US subsidiary Glenmark Generics’s new drug application (NDA) for pain management drug Oxycodone Hydrochloride has been accepted by the US regulator Federal Drug Administration. The Sensex, in contrast, fell 0.35% to 17,527.77 points.

Glenmark’s drug, which is expected to be approved in 10 months, could potentially give it market exclusivity in the US market for this product as it has a head start on clinical trials. The drug is currently marketed by several companies under an exceptional provision called “grandfathered" drug as there were no proper clinical trial records available.

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