Cornerstone announces ANDA filing for generic Tussionex

Cornerstone Therapeutics Inc. (Nasdaq: CRTX) ("Cornerstone" or the "Company"), a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that its product candidate CRTX-067 is an ANDA filing for a generic 10 mg chlorpheniramine polistirex/8 mg hydrocodone polistirex suspension product that will be a generic substitute for the product currently sold under the Tussionex brand name by UCB, Inc.

"This product offers substantial revenues in 2011 and exciting growth potential," said Craig A. Collard, Cornerstone's President and Chief Executive Officer.  "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."

This announcement immediately follows the announcement of the Company's decision to cease manufacturing and distribution of marketed unapproved drugs, and to focus its growth strategy exclusively on products with long-term revenue potential, intellectual property and NDA or ANDA approvals.