FDA approves new formulation Vaprisol

The U.S. Food and Drug Administration has approved Astellas Pharma US, Inc.’s new Vaprisol (conivaptan hydrochloride injection) premixed in 5% Dextrose. An arginine vasopressin (AVP) receptor antagonist, Vaprisol is the only drug approved and indicated for use in the treatment of patients with either kind of hyponatremia – euvolemic or hypervolemic. Its single-use (100ml) premixed formulation is available in an INTRAVIA(R) Container. The latest formulation will simplify preparation as it requires no mixing or measuring. Its safe usage period is six months longer than the original ampule formulation.

Teva introduces Nicardipine HCl Injection in US

Teva Pharmaceutical Industries Ltd. has introduced its  Nicardipine Hydrochloride Injection, 2.5 mg/mL, in the United States of America. The injection is the first alternative to EKR Therapeutics’ treatment for high blood pressure, Cardene® I.V. According to IMS sales data, this product had annual sales of approximately $181 million in the United States from July 2007 to June 2008. As part of an agreement that Teva and Exela PharmSci, Inc. (a Reston, Virginia based company developing pharmaceuticals), entered into, Teva is licensed to manufacture and distribute the  Nicardipine HCl Injection.