Description
Cornerstone Therapeutics, Inc., a Delaware Corporation founded in 2000. The Company is a specialty pharmaceutical company which commercializes products for the hospital and adjacent specialty markets. Its currently marketed and approved products include: CARDENE I.V., an FDA-approved premixed injection indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable; CUROSURF, an FDA-approved natural lung surfactant indicated for the treatment of Respiratory Distress Syndrome, or RDS, in premature infants; ZYFLO, the only FDA-approved leukotriene synthesis inhibitor indicated for prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older; BETHKIS, an inhaled tobramycin-based product indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa, or PA, approved by the FDA in October 2012; Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Suspension, or HP/CP ER Suspension, an FDA approved antitussive/antihistamine combination product that is a generic equivalent for the product currently sold under the Tussionex Pennkinetic,or Tussionex, brand name in the United States. Its customers consist of drug wholesalers, retail drug stores, mass merchandisers and grocery store pharmacies in the United States. It primarily sell products directly to drug wholesalers, which in turn distribute the products to retail drug stores, hospitals, mass merchandisers and grocery store pharmacies. It currently outsources the manufacturing of all of its commercially available products and the formulation development of its product candidates for use in clinical trials to third parties. It have U.S. and/or foreign trademark registrations and filings for certain of its corporate names, products (including CARDENE I.V., ZYFLO CR and ZYFLO) and product candidates (including RETAVASE and LIXAR). CUROSURF and BETHKIS are owned by Chiesi and are licensed to it for sales and marketing purposes in the United States. The Company faces competition from many different sources, including commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies and private and public research institutions. The Company, its contract manufacturers and packagers, and its products and product candidates are subject to the Controlled Substances Act and DEA regulations thereunder.