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ARTICLE | Company News

Cornerstone Therapeutics, Exela PharmSci Inc. cardiovascular news

June 17, 2013 7:00 AM UTC

Cornerstone received a Paragraph IV notification letter from Exela PharmaSci's Exela Pharma Sciences LLC (Lenoir, N.C.) subsidiary indicating that it submitted an sNDA to FDA for an injectable formulation of 0.1 and 0.2 mg/mL nicardipine in 0.9% sodium chloride. Cornerstone markets an injectable formulation of 0.1 and 0.2 mg/mL nicardipine in 0.86% sodium and 0.83% chloride as Cardene I.V. Premixed Injection to treat hypertension. The company said it is reviewing the letter and plans to pursue all available avenues in defense of Cardene I.V. ...