USFDA Drug approvals (december 2007)

NCE and generics approved/ tentatively approved or revisions by USFDA in the month of December (till 23rd Decemeber).
Amlodipine Besylate Tablets, Caraco Pharma, Approval
Atrovent (ipratropium bromide) Nasal Spray, Boehringer Ingelheim, Labeling Revision
Calcium Acetate Capsules, Roxane Labs, Tentative Approval
Diovan (valsartan) Tablets. Novartis Pharma, Patient Population Altered
Granisetron Hydrochloride Injection, Abraxis Pharma, Approval
Letairis (ambrisentan) Tablets, Gilead Sciences, Labeling Revision
Metoclopramide Tablets, Northstar Healthcare, Approval
Ondansetron Oral Solution, Taro Pharma, Approval
SARAFEM (fluoxetine hydrochloride) Tablets, Warner Chilcott, Labeling Revision
Tenofovir Disoproxil Fumarate Tablets, Matrix Labs, Tentative Approval
Triesence (triamcinolone acetonide) Injectable Suspension, Alcon Research, Approval
Colgate Total (sodium fluoride & triclosan) Toothpaste, Colgate-Palmolive, Formulation Revision
Donepezil Hydrochloride Tablets, Ranbaxy, Tentative Approval
INOmax (nitric oxide) Inhalation, INO Therapeutics Inc., Labeling Revision
Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Omeprazole Delayed-Release Tablets, Dexcel Pharma, Approval
Phenytoin Sodium Injection, PharmaForce Inc., Approval
Pregnyl (chorionic gonadotropin) Injection, Organon Inc., Labeling Revision
REBETOL (ribavirin) Capsules and Oral Solution, Schering Corp., Labeling Revision
Venofer (Iron Sucrose) Injection, Luitpold Pharma, Labeling Revision
Gonal-f RFF Pen (follitropin alfa) Injection, EMD Serono, Manufacturing Change or Addition
Lovaza (omega-3-acid ethyl esters) Capsules, Reliant Pharma, Manufacturing Change or Addition
Mevacor (lovastatin) Tablets, Merck & Co., Manufacturing Change or Addition
Aredia (pamidronate disodium) Injection, Novartis Pharma, Labeling Revision
Ciprofloxacin Extended-release Tablets, Sandoz Inc., Approval
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, Hill Dermaceuticals, Patient Population Altered
Kuvan (sapropterin) Tablets, BioMarin, Approval
Lamotrigine Tablets, Mylan Pharma, Tentative Approval
Oxcarbazepine Tablets, Teva Pharma, Approval
Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision
Sonata (zaleplon) Capsules, King Pharma, Labeling Revision
Valtrex (valacyclovir hydrochloride) Caplets, GlaxoSmithKline, Labeling Revision
Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision
Vyvanse (lisdexamfetamine dimesylate) Capsules, New River Pharma, Manufacturing Change or Addition
Zetia (Ezetimibe) Tablets, Schering Corp., Labeling Revision
AndroGel (testosterone) Gel, Solvay Pharma, Labeling Revision
Bleomycin Injection, Pharmachemie B.V., Approval
Floxin (ofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
Levaquin (levofloxacin) Injection and Levaquin (levofloxacin in 5% dextrose) Injection, Ortho-McNeil Pharma, Labeling Revision
Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Labeling Revision
LEXIVA (fosamprenavir calcium, FPV) Oral Tablets, GlaxoSmithKline, Labeling Revision
Ranitidine Oral Solution Syrup, Ranbaxy, Approval
Stavudine Capsules, Emcure Pharma, Tentative Approval
Cefdinir Oral Suspension, Aurobindo Pharma, Approval
DepoDur (morphine sulfate extended-release liposome) Injection, Pacira Pharma, Labeling Revision
Effexor XR (venlafaxine HCl) Extended-Release Capsules, Wyeth Pharma, New Modified Indication
Heparin Sodium Injection, Abraxis Pharma, Labeling Revision
Heparin Sodium Injection Baxter Healthcare, Labeling Revision
LEXIVA (fosamprenavir calcium) Oral Tablets, GlaxoSmithKline, Labeling Revision
Methimazole Tablets, Actavis, Approval
Omniscan (gadodiamide) Injection, GE Healthcare, Labeling Revision
Paromomycin Sulfate Capsules, X-Gen Pharma, Approval
Thyrogen (thyrotropin alfa) Injection, Genzyme Corp., New or Modified Indication
Buspirone Hydrochloride, Tablet, Actavis Totowa, Approval
Bystolic (nebivolol), Tablet, Mylan Bertek, Approval
Efavirenz, Tablet, Emcure, Tentative Approval
Extended Phenytoin Sodium, Capsule, Wockhardt, Approval
Levalbuterol Hydrochloride, Inhalation Solution, Breath Ltd, Tentative Approval
Metronidazole, Topical Cream, G & W Laboratories, Approval
Pantoprazole Sodium, Extended Release Tablet, Dr. Reddy's Labs, Tentative Approval