Drug Store News - Watson’s generic Vasotec gets OK
The FDA has tentatively approved Watson’s abbreviated new drug application for Enalapril Maleate tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. Enalapril Maleate is the generic equivalent of Merck’s ACE-inhibitor Vasotec. Watson said final approval of the ANDA may not be received prior to August 22, when pediatric exclusivity will expire.
Related Results
FDA unleashes 16 generics of VasotecMerck gets good news on VasotecENALAPRIL.(Vasotec from Merck)(Company Business and Marketing)(Brief Article)Biovail Corp. (Active Pharmaceutical Ingredient Watch).(purchase of Vasotec,…Biovail Acquires Vasotec-R/Vaseretic-R From Merck And Co., Inc.
Aventis, the firm’s contract manufacturer, will produce the drug for Watson in Cincinnati. Eight other generic manufacturers, including ESI Lederle, Teva and Apothecon hold tentative approvals for generic formulations of Vasotec.
COPYRIGHT 2000 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2008 Gale, Cengage Learning
