Zydus Cadila receives US FDA approvals for Clindamycin

Ahmedabad: Zydus Cadila has received US FDA approval to market Clindamycin, an anti-infective drug, in the US market. With this, Zydus Cadila has now received approvals to market two out of the seven drugs expected to be launched this year. The company had received US FDA approval for its anti-hypertensive, atenolol. According to IMS data for 2003, the total US market for this drug is estimated at $87 million.

Zydus Cadila set up Zydus Pharmaceuticals USA, Inc on January 14, 2004, and filed 12 ANDAs (abbreviated new drug applications) on April 1 for drugs estimated at $7.4 billion. On July 15, the company''s Moraiya plant received the US FDA approval, followed by approvals for atenolol and clindamycin coming in within 24 hours of each other.

According to Pankaj R Patel, chairman and managing director, Zydus Cadila, "With the approvals coming in, we are all set to make an entry in the US generic market. It brings to fruition our efforts over the last two years in creating a strong regulatory pipeline and infrastructure and building a strong platform for our US operations."