Forest Laboratories Receives FDA Approvable Letter For Oxycodone HCl/Ibuprofen
NEW YORK, Oct. 21 /PRNewswire-FirstCall/ — Forest Laboratories, Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration (FDA) concluded the Company's New Drug Application for its investigational treatment oxycodone HCl/ibuprofen was approvable.
Oxycodone HCl/ibuprofen is a patented combination of oxycodone, an opioid analgesic, and ibuprofen, one of the most widely used non-steroidal anti-inflammatory drugs. Oxycodone HCl/ibuprofen is licensed to Forest Laboratories from BTG (LSE: BGC).
The FDA requested that the Company conduct additional clinical trials to
further establish the safety and efficacy of the product. Forest plans to
have further communication with the FDA to discuss the questions contained in
the approvable letter in order to determine the appropriate next steps in the
approval process. Subsequent to this communication, Forest will be better
able to project the timing for approval and launch of the product.