New and Generic Drug Approvals

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Actiq	fentanyl citrate	Troche/Lozenge;Transmucosal	Cephalon	Manufacturing Change or Addition
Altoprev	lovastatin	Tablet, Extended Release;Oral	Andrx Labs Llc	Labeling Revision
Besivance	besifloxacin hydrochloride	Suspension/Drops;Ophthalmic	Bausch and Lomb	Manufacturing Change or Addition
Cardene	nicardipine hydrochloride	Injectable;Injection	Ekr Therap	Manufacturing Change or Addition
Cardene In 0.83% Sodium Chloride In Plastic Container	nicardipine hydrochloride	Injectable;Intravenous	Ekr Therap	Manufacturing Change or Addition
Cardene In 0.86% Sodium Chloride In Plastic Container	nicardipine hydrochloride	Injectable;Intravenous	Ekr Therap	Manufacturing Change or Addition
Cardene In 4.8% Dextrose In Plastic Container	nicardipine hydrochloride	Injectable;Intravenous	Ekr Therap	Manufacturing Change or Addition
Cardene In 5.0% Dextrose In Plastic Container	nicardipine hydrochloride	Injectable;Intravenous	Ekr Therap	Manufacturing Change or Addition
Eliquis	apixaban	Tablet;Oral	Bristol Myers Squibb	Manufacturing Change or Addition
Ellipta	umeclidinium bromide	Powder;Inhalation	Glaxo Grp Ltd	Approval
Epi E Z Pen Jr	epinephrine	Injectable;Intramuscular	Mylan Speclt	Labeling Revision
Epipen	epinephrine	Injectable;Intramuscular, Subcutaneous	Mylan Speclt	Labeling Revision
Epipen E Z Pen	epinephrine	Injectable;Intramuscular	Mylan Speclt	Labeling Revision
Epipen Jr.	epinephrine	Injectable;Intramuscular, Subcutaneous	Mylan Speclt	Labeling Revision
Gilenya	fingolimod	Capsule;Oral	Novartis	Labeling Revision
Nicoderm Cq	nicotine	Film, Extended Release;Transdermal	Sanofi Aventis Us	Labeling Revision
Soliris	eculizumab	Injectable; Iv (Infusion)	Alexion Pharm	Efficacy Supplement with Clinical Data to Support
Soliris	eculizumab	Injectable; Iv (Infusion)	Alexion Pharm	Labeling Revision
Xenical	orlistat	Capsule;Oral	Hoffmann La Roche	Manufacturing Change or Addition