FDA Approves Cornerstone Therapeutics' ANDA for Generic Tussionex Pennkinetic Product

Cornerstone Therapeutics Inc.

today announced that the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (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 (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.