Zydus Cadila gets USFDA nod to market two drugs

 Ahmedabad January 10, 2014: Ahmedabad-based firm has also received USFDA approval to market Duloxetine delayed release capsules in different strengths

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.

Earlier in 2013, the company had received USFDA nods for a number of other drugs. Zydus had received the phase one clinical trial approval from the USFDA for ZYDPLA1, a novel next generation new chemical entity that would offer once a week oral treatment option for Type-2 diabetic patients in October 2013. In August, the company had  received the final approval from the USFDA to market Lansoprazole DR Capsules in different strengths of  15 mg and 30 mg.-Business Standard