Zydus Cadila on Thursday said it has received the final approval from the USFDA to market Sirolimus tablets (0.5 mg) with 180-days of marketing exclusivity.
As per IMS data in 2013, the sales of Sirolimus 0.5 mg was estimated at $11.7 million and the total market for Sirolimus was approximately $203.8 million, the Ahmedabad-based company said in a statement here.
The Group also received approval for Duloxetine delayed release capsules in strengths of 20, 30 and 60 mg. 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.
The Zydus Group now has 86 approvals and has so far filed 216 ANDAs since the commencement of filing process in FY 2003-04.