Cornerstone seeks FDA approval for generic Tussionex

CARY, N.C. Generic drug maker Cornerstone Therapeutics has filed for approval of a treatment for cold symptoms, Cornerstone said Thursday.

The drug maker announced the filing of an application with the Food and Drug Administration for CRTX-067 (chlorpheniramine polistirex and hydrocodone polistirex) oral suspension, a generic version of UCB’s Tussionex.

“This product offers substantial revenues in 2011 and exciting growth potential,” Cornerstone president and CEO Craig Collard said. “Resolving the uncertainty around 067 underlines Cornerstone’s commitment to focus on the development of its cough and cold franchise. We continue to expect that the expedited review of 067 will result in FDA approval in early 2011.”

The announcement follows Cornerstone’s decision to cease manufacturing and distribution of unapproved drugs and to focus its strategy on products with long-term sales potential.