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FDA Approves Generic Tussionex-Pennkinetic Product

Coating Place to supply patent-protected API

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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 ...

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