Generic Launches

Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date

July 15, 2013

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Reclast	Novartis	Zoledronic Acid Injection	Dr. Reddy's Laboratories	osteoporosis	4/3/2013
Zovirax Ointment	Valeant Pharma. Int'l	Acyclovir Ointment USP, 5%	Mylan	management of initial genital herpes	4/3/2013
Zovirax	Valeant Pharma. Int'l	Acyclovir 5% Ointment	Actavis Inc(ACT)	management of initial genital herpes	4/5/2013
Zovirax	Valeant Pharma. Int'l	Acyclovir 5% Tape	Actavis Inc(ACT)	treatment of inflammation and itching	4/5/2013
Seasonique Tablets	Teva	Levonorgestrel / Ethinyl estradiol	Lupin Pharmaceuticals	use by women to prevent pregnancy	4/12/2013
Lysteda	Ferring	Tranexamic Acid	Prasco	cyclic heavy menstrual bleeding	5/1/2013
Zomig	AstraZeneca	Zolmitriptan	Glenmark Generics Inc.	acute treatment of migraine headaches in adults	5/15/2013
Zomig ZMT	AstraZeneca	Zolmitriptan ODT	Glenmark Generics Inc.	acute treatment of migraine headaches in adults	5/15/2013
Zomig Tablets	IPR Pharmaceuticals	Zolmitriptan Tablets	Mylan	acute treatment of migraine with or without aura in adults	5/15/2013
Zomig	AstraZeneca	Zolmitriptan	Apotex	acute treatment of migraine headaches in adults	5/15/2013
Zomig-ZMT	AstraZeneca	Zolmitriptan ODT	Apotex	acute treatment of migraine headaches in adults	5/15/2013
Tricor Tablets	Abbvie	Fenofibrate Tablets	Mylan	adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia	5/17/2013
Atacand	AstraZeneca	Candesartan Cilexetil Tablets	Sandoz	heart failure in adults with left ventricular systolic dysfunction, and hypertension in adults and children 1 to 17 years of age	5/22/2013
Sanctura XR	Allergan	Trospium Chloride	Perrigo Co(PRGO)	bladder dysfunction	5/29/2013
Depo-Testosterone Injection	Pfizer	Testosterone Cypionate Injection	Sun Pharma	replacement therapy in the male associated with symptoms of deficiency or absence of endogenous testosterone	6/4/2013
Rilutek	Covis Pharma	Riluzole Tablets	Glenmark Generics	treatment of amyotrophic lateral sclerosis	6/19/2013
Lamictal XR	GlaxoSmithKline	Lamotrigine Extended-Release	Dr. Reddy's Laboratories	seizure disorders and bipolar disorders	6/25/2013
Micronor Tablets	Janssen Pharmaceuticals	Norethindrone Tablets	Mylan	prevention of pregnancy	6/26/2013