The FDA has approved the ANDA for CTRX 067, a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension. CRTX 067 was developed through a collaboration including Cornerstone Therapeutics, Coating Place, Inc. (CPI) and NEOS Therapeutics.

Cornerstone will market the product through its wholly-owned generics subsidiary, Aristos Pharmaceuticals. Coating Place will manufacture and supply the APIs, including a patent-protected version of time-released hydrocodone and chlorpheniramine polistirex drug resin complex (DRC). These active substances will be manufactured at commercial scale in the CPI facilities. NEOS developed the CRTX 067 drug product formulation using its proprietary suspension formulation technology, Dynamic Time Release Suspension (DTRS). Cornerstone will begin manufacturing the generic antitussive/antihistamine product immediately.

“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 ongoing industry challenges related to manufacturing prescription cough and cold medications, this is yet another opportunity for growth within the organization. We are well positioned to supply product to meet increased demand and patient needs.”

According to a press statement, Cornerstone anticipates a strong opportunity for the product, despite competition from other generics, given the market demand that exists. Antitussives are some of the most commonly prescribed medications during cough and cold season.

Net sales for Tussionex and related generics were $127 million in 2011 according to IMS Health’s NSP™, a third-party provider of prescription data. Cornerstone intends to utilize its existing relationships in the respiratory field and distribution expertise to effectively gain market share for its generic product.