New and Generic Drug Approvals

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Atnaa	atropine; pralidoxime chloride	Injectable;Intramuscular	Us Army	Manufacturing Change or Addition
Claritin	loratadine	Syrup;Oral	Schering Plough	Manufacturing Change or Addition
Claritin Hives Relief	loratadine	Syrup;Oral	Schering Plough	Manufacturing Change or Addition
Desonide	desonide	Cream;Topical	Perrigo New York	Manufacturing Change or Addition
Invokana	canagliflozin	Tablet;Oral	Janssen Pharms	Labeling Revision
Izba	travoprost	Solution;Ophthalmic	Alcon Labs Inc	Approval
Lunesta	eszopiclone	Tablet;Oral	Sunovion Pharms Inc	Labeling Revision
Nutropin Aq	somatropin recombinant	Injectable;Injection	Genentech	Manufacturing Change or Addition
Nutropin Aq Pen	somatropin recombinant	Injectable;Injection	Genentech	Manufacturing Change or Addition
Olanzapine	olanzapine	Tablet, Orally Disintegrating;Oral	Aurobindo Pharma Ltd	Approval
Opana Er	oxymorphone hydrochloride	Tablet, Extended Release;Oral	Endo Pharms	Manufacturing Change or Addition
Oxytrol For Women	oxybutynin	Film, Extended Release;Transdermal	Msd Consumer	Manufacturing Change or Addition
Prilosec Otc	omeprazole magnesium	Tablet, Delayed Release;Oral	Astrazeneca	Manufacturing Change or Addition
Taxotere	docetaxel	Injectable;Injection	Sanofi Aventis Us	Manufacturing Change or Addition
Trivagizole 3	clotrimazole	Cream;Vaginal	Taro	Manufacturing Change or Addition
Xarelto	rivaroxaban	Tablet; Oral	Janssen Pharms	Manufacturing Change or Addition