Marksans Pharma Ltd. secured U.S. FDA approval to market a generic version of GlaxoSmithKline PLC's Avodart for the treatment of benign prostatic hyperplasia, or BPH.
BPH is an age-associated prostate gland enlargement that can cause urination difficulty. The Indian pharmaceutical said it will launch dutasteride soft gelatin capsules in dosages of 0.5 milligrams immediately.
Elsewhere, the company noted that the U.S. FDA recorded four violations during an inspection of its manufacturing facility in Goa, India.
Marksans said it had already started addressing the issues.