
Drug company Marksans Pharma today said that the FDA, the US health regulator has issued four observations, none of them critical, after completing the inspection of its Verna manufacturing unit in Goa. Previously UK's drug regulator has conducted an inspection of the same Verna facility in February this year, and had no observations.
Marksans shares have been trading up on the news that the FDA has granted final approval for Marksan's application for Dutasteride Soft Gelatin Capsules, which is generically equivalent to Avodart capsules by GlaxoSmithKline. Dutasteride is used for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The company said that it planned to launch the product immediately in the US market.