Zydus Cadila gets FDA nod to market two drugs

Company will market Sirolimus tablets which are immuno-supressants and Duloxetine which is anti-depressant

Ahmedabad-based Zydus Cadila received the final approval from the US drug regulator to market one immuno-supressant and one anti-depressant drug in the US market.

Zydus today informed that it received the nod to market Sirolimus tablets of strength 0.5 mg with 180 days of marketing exclusivity, together with the nod to market Duloxetine delayed release capsules in different strengths of 20 mg, 30 mg and 60 mg.

As per IMS data the sales of Sirolimus 0.5mg was estimated at $11.7 million and the total market for Sirolimus was approximately $203.8 million in 2013. The sales for Duloxetine was estimated at $5.5 billion in 2013.

 

While Sirolimus tablets are immuno-suppressant drugs used to prevent rejection in organ transplantation, Duloxetine delayed release capsules fall in the anti-depressants segment.
 
The group now has 86 approvals and has so far filed 216 ANDAs since the commencement of filing process in FY 2003-04.