Zydus Cadila gets USFDA nod to sell drugs in the US market

NEW DELHI: Drug firm Zydus Cadila on Thursday said it has received approval from the US health regulator to sell Sirolimus Tablets, used to prevent rejection in organ transplantation, in the American market with 180 days of marketing exclusivity.

"Zydus Cadila received the final approval from the US Food and Drug Administration (USFDA) to market Sirolimus tablets 0.5 mg with 180 days of marketing exclusivity," the company said in a statement.

The Ahmedabad-based firm has also received USFDA approval to market Duloxetine delayed release capsules in different strengths of 20 mg, 30 mg and 60 mg, it added.

As per the IMS data in 2013, the sales of Sirolimus 0.5 mg is estimated at $11.7 million and the total market for Sirolimus stood at around $203.8 million.

The sales for Duloxetine was estimated at $5.5 billion in 2013.

While Sirolimus tablets are immunosuppressant drugs used to prevent rejection in organ transplantation, Duloxetine delayed release capsules fall in the anti-depressants segment.