Cornerstone Therapeutics Inc. (CRTX) announced that the U.S. Food and Drug Administration or FDA approved its Abbreviated New Drug Application or ANDA for 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 or 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 or DTRS, and Neos will be the exclusive manufacturer of the approved drug product.
Cornerstone stated that it 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.
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