NEW YORK The Food and Drug Administration has given tentative approval to Dr. Reddy’s Labs for a generic asthma drug, according to published reports.
Reuters reported Wednesday that Dr. Reddy’s got tentative approval for zafirlukast, a generic version of AstraZeneca’s Accolate. Accolate had global sales of $66 million in 2009, according to AstraZeneca financial data.
Tentative approval means that the generic version meets the FDA’s conditions for approval but cannot be launched until the patents covering the branded version expire. The last patent covering Accolate expires in March 2014, according to FDA records.