FDA Update, 7/5/2008

New and Generic Drug Approvals


amitriptyline hydrochloride tablets, (antidepressant)Caraco Pharmaceutical Laboratories, Ltd., Approval
Aptivus (tipranavir) Oral Solution, (treatment for AIDS and HIV)Boehringer Ingelheim Pharmaceuticals, Inc., Approval
azithromycin oral suspension, (treat bacterial infections)Teva Pharmaceuticals USA, Approval
betaxolol hydrochloride tablets, (beta blocker)KVK-Tech, Inc., Approval
dronabinol capsules, (Marinol) (1. Treatment of loss of appetite in AIDS patients. 2. Nausea and vomiting in cancer patients) Par Pharmaceutical, Inc., Approval
epoprostenol injection, (Flolan) (pulmonary hypertension) GeneraMedix, Inc., Approval
famotidine injection, (Pepcid) (heartburn) Akorn-Strides, LLC, Approval
PrandiMet (repaglinide and metformin hydrochloride) Tablets, (type 2 diabetes) Novo Nordisk, Inc., Approval