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………



View original post


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s