Cornerstone Therapeutics, a specialty pharmaceutical company, has received FDA approval for its abbreviated new drug application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product.
The generic equivalent for the product currently sold under the Tussionex Pennkinetic brand name 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.
Cornerstone is expected to begin manufacturing its generic antitussive/antihistamine product immediately.
Cornerstone chief executive officer Craig Collard said, "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."
CRTX 067 was developed through a collaboration including Cornerstone, Coating Place, and Neos Therapeutics, a subsidiary of Neos Therapeutics.
Cornerstone will market the product through its wholly-owned generics subsidiary, Aristos Pharmaceuticals.
