Glenmark Pharmaceuticals Ltd said its subsidiary Glenmark Generics Ltd received an abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for its norethindrone acetate tablets in 5mg. The company will start marketing and distribution of the product in the US immediately.
Norethindrone Acetate is the generic version of Duramed Research Inc's aygestin and is used for the treatment of secondary amenorrhea, endometriosis and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology such as submucous fibriods or uterine cancer.
On Thursday, Glenmark Pharma shares ended 0.9% down at Rs280 on the Bombay Stock Exchange, while the Sensex closed 0.8% up at 18,113 points.
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