FDA Approves Cornerstone Therapeutics' ANDA

Cornerstone Therapeutics Inc. recently announced FDA approval of its ANDA for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension.

CRTX 067 was developed through a collaboration including Cornerstone Therapeutics, Coating Place, Inc., and NEOS Therapeutics. Cornerstone will market the product through its wholly owned generics subsidiary, Aristos Pharmaceuticals, Inc. Coating Place manufactures and supplies 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).

“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.”

Cornerstone will begin manufacturing its generic antitussive/antihistamine product immediately. Despite competition from other generics, Cornerstone anticipates 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. 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.

Cornerstone Therapeutics Inc., headquartered in Cary, NC, is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory, and related specialty markets. Key elements of the company’s strategy are to focus its commercial and internal development efforts in the hospital and related specialty product sector within the US pharmaceutical marketplace; continue to seek out opportunities to acquire companies and marketed and/or registration-stage products that fit within the company’s focus areas; and generate revenues by marketing approved generic products through the company’s wholly owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit www.crtx.com.

Neos Therapeutics Inc. is a specialty pharmaceutical company focused on the development, manufacture, and sale of FDA-approved drug products that utilize the company’s proprietary delivery technologies. Neos’ drug products are developed using the Dynamic Time Release Suspension (DTRS) and Rapidly Disintegrating Ionic Masking (RDIM) technologies, that deliver controlled-release (CR) small molecule APIs in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are FDA-approved and known to be safe and effective, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s 505(b)(2) NDA approval process. For more information, visit www.neostx.com.

Coating Place is an established niche pharmaceutical company specializing in Wurster fluid bed technology focused on drug delivery system development and contract manufacturing. It provides customers with modified- and extended-release bulk active products through innovative development, unique manufacturing capabilities, and integrated quality philosophy. CPI’s extended-release drug-resin APIs were developed using its patented DRC Technology combined with its trade secret linear scale-able Wurster manufacturing process. For more information, visit www.coatingplace.com.