Marksans Pharma gets final approval for Dutasteride Soft Gelatin Capsules
From USFDA
Marksans Pharma announced that on 07 April 2017, the USFDA has granted final approval of the Abbreviated New Drug Application for Dutasteride Soft Gelatin Capsules 0.5 mg, which is therapeutically equivalent to the reference listed drug (RLD), Avodart Capsules, 0.5 mg of GlaxoSmithKline.Durasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Marksans will launch the product immediately.
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First Published: Apr 10 2017 | 12:48 PM IST