FDA Grants Forest Drug Combo QIDP Status

New Drug Approvals

Ceftazidime/avibactam Combination Receives Qualified Infectious Disease Product (QIDP) Designation from FDA

NEW YORK–(BUSINESS WIRE)–Sept. 12, 2013–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………

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http://www.pharmalive.com/fda-grants-forest-drug-combo-qidp-status

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