Wockhardt Drug Gets India's First U.S. QIDP Fast-Track Status
This article was originally published in PharmAsia News
Executive Summary
Wockhardt has become the first India drug maker to receive U.S. FDA Qualified Infectious Disease Product status, a fast-track review designation, for two versions of its anti-MRSA drug.
Wockhardt has become the first India drug maker to receive U.S. FDA Qualified Infectious Disease Product status, a fast-track review designation, for two versions of its anti-MRSA drug. The QIDP designation also gives a drug an additional five years of patent protection. The quinolone drugs, WCK 771 intravenous and WCK 2349 oral tablet version, are to enter Phase III studies in the U.S. early next year. (Click here for more
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"USFDA Grants QIDP Status To Two Wockhardt Drugs" - Business Standard (India) (8/31/2014)