Zydus receives tentative approval from the USFDA for Abacavir and Lamivudine Tablets USP

Wednesday, Aug 09, 2017

Zydus Cadila has received the tentative approval from the USFDA to market Abacavir  and
Lamivudine Tablets USP, 600 mg/300 mg.The drug is indicated for use in antiretroviral
combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection
and will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad.
The sales of Abacavir and Lamivudine Tablets is estimated at $240.2 million.Source: IMS Health, IMS National Sales Perspective Audit, MAT June 2017, extracted August 2017.

The group now has more than 130 approvals and has so far filed over 300 ANDAs since the
commencement of the filing process in FY 2003-04.

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