Market Overview

Forest Lab's Ceftazidime/avibactam Combination Receives Qualified Infectious Disease Product Designation from FDA

Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical
manufacturer and marketer, today announced that the U.S. Food and Drug
Administration (FDA) has designated its investigational drug,
ceftazidime/avibactam, a qualified infectious disease product (QIDP).
The QIDP designation was created by the Generating Antibiotic Incentives
Now (GAIN) Act, which was part of the FDA Safety and Innovation Act
(FDASIA), which was signed into law in 2012. The QIDP designation
provides certain incentives for the development of new antibiotics,
including priority review and eligibility for the FDA's fast track
program, and a five-year extension of exclusivity under the Hatch-Waxman
Act.

Ceftazidime/avibactam is currently in Phase III trials to investigate
efficacy in treating

See full press release

Posted-In: News Guidance Contracts Management Global

 

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