I.V. pentamidine
Executive Summary
FDA approves Astra Pharmaceutical's ANDA suitability petition for pentamidine isethionate injection, 100 mg/ml in 3 ml vials on Jan. 18. Request was for a change in formulation from the lyophilized powder of Lyphomed's Pentam 300 to a solution. Lyphomed's marketing exclusivity for Pentam expires Oct. 16, 1991.
FDA approves Astra Pharmaceutical's ANDA suitability petition for
pentamidine isethionate injection, 100 mg/ml in 3 ml vials on Jan.
18. Request was for a change in formulation from the lyophilized
powder of Lyphomed's Pentam 300 to a solution. Lyphomed's marketing
exclusivity for Pentam expires Oct. 16, 1991. |