The US Food and Drug Administration (FDA) has approved Cornerstone Therapeutics' Abbreviated New Drug Application (ANDA), a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product.

The antitussive/antihistamine combination product is a generic equivalent for the product currently sold under the Tussionex Pennkinetic brand name. The product is indicated for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children six years of age and older.

CRTX 067 was developed through a collaboration including Cornerstone, Coating Place, Inc. and Neos Therapeutics, LP, a subsidiary of Neos Therapeutics, Inc. Cornerstone will market the product through its wholly-owned generics subsidiary, Aristos Pharmaceuticals, Inc. Coating Place manufactures and supplies the active pharmaceutical ingredients (APIs), including a patent-protected version of hydrocodone polistirex. Neos developed the CRTX 067 drug product formulation using its proprietary formulation technology, Dynamic Time Release Suspension (DTRS), and Neos will be the exclusive manufacturer of the approved drug product.

“We are pleased with the FDA's decision to approve our generic antitussive/antihistamine product,” said Craig A Collard, Cornerstone's Chief Executive Officer. “Given the recent industry challenges and changes related to prescription cough and cold medications, this product affords patients an approved generic drug product alternative as well as providing Cornerstone the opportunity for growth.”

Collard added, “While Cornerstone recently completed its strategic shift away from primary care, one of our main goals through Aristos is to continue to seek out and introduce opportunistic generic products. The addition of a generic Tussionex to Aristos' product portfolio is yet another successful execution of this plan.”

Cornerstone will begin manufacturing its generic antitussive/antihistamine product immediately. Despite competition from other generics, Cornerstone believes that there is a strong market opportunity given the demand that exists within this market. Antitussives are some of the most commonly prescribed medications during cough and cold season. Total prescriptions for Tussionex and related generics were 2.59 million in 2011 according to IMS Health, a third-party provider of prescription data. This represents a 2% increase in prescription volume as compared to 2010. Cornerstone management believes its distribution expertise will allow Cornerstone to effectively gain market share for its generic product.

Cornerstone Therapeutics Inc., headquartered in Cary, North Carolina, is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related specialty markets.