Generic Launches

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

April 16, 2013

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Propecia	Merck Sharp & Dohme	Finasteride	Dr. Reddy's Labs	male pattern hair loss	1/2/2013
Maxalt	Merk	Rizatriptan Benzoate Tablets	Glenmark Generics	migraine with or without aura in adults	1/2/2013
Maxalt MLT and Maxalt	Merck	Rizatriptan Benzoate Orally Disintegrating, Rizatriptan Benzoate Tablets	Mylan Phamaceuticals	migraine with or without aura in adults	1/2/2013
Maxalt MLT and Maxalt	Merk	Rizatriptan benzoate	Par Pharmaceutical	migraine with or without aura in adults	1/2/2013
Romazicon	Hoffmann La Roche	Flumazenil Injection, USP	Sagent Pharmaceuticals	reversal of the sedative effects of benzodiazepines.	1/2/2013
Lysteda	Ferring	Tranexamic Acid	Prasco	cyclic heavy menstrual bleeding	1/7/2013
Acetadote	Cumberland Pharmaceuticals	Acetylcysteine injection	Perrigo	hepatic injury	1/7/2013
Lamictal XR	GlaxoSmithKline	Lamotrigine	Wockhardt	epilepsy	1/8/2013
Duetact	Takeda Pharmaceuticals	Pioglitazone Hydrochloride and Glimepiride tablets	Sandoz	control of blood sugar in adults with type 2 diabetes mellitus.	1/11/2013
Luxiq Foam	Cobrek Pharmaceuticals	Betamethasone valerate foam 0.12%	Perrigo	scalp psoriasis	1/15/2013
Lamictal XR	GlaxoSmithKline	Lamotrigine ER	Par Pharmaceutical	adjunctive therapy for partial onset seizures	1/18/2013
Nicorette Mini	GlaxoSmithKline	Nicotine polacrilex mini lozenge USP	Perrigo	reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking	1/22/2013
Bactroban	GlaxoSmithKline	Mupirocin	Glenmark Generics	secondarily infected traumatic skin lesions	1/24/2013
Bactroban	GlaxoSmithKline	Mupirocin (authorized generic)	Prasco	secondarily infected traumatic skin lesions	1/24/2013
Olux-E	GlaxoSmithKline	Clobetasol Emulsion Propionate foam, 0.05%	Perrigo	moderate to severe dermatosis of the scalp	2/1/2013
Doxil	Janssen	Doxorubicin HCl	Sun Pharma	ovarian cancer that progressed or recurred after platinum-based chemotherapy. AIDS related Kaposi's sarcoma; combination with Velcade for multiple myeloma	2/4/2013
Cleocin Phosphate®	Pharmacia and Upjohn	Clindamycin in 5% Dextrose in minibag form	Sandoz	serious bacterial infections	2/6/2013
Argatroban	Eagle Pharmaceutical	Argatroban injection 50 mg/50mL, aqueous solution (1 mg/mL)	Sandoz	thrombosis in adult patients with heparin-induced thrombocytopenia.	2/19/2013
Suboxone	Rickitt Benckiser Healthcare	Buprenorphine HCl and Naloxone HCl Dihydrate SL	Actavis	pain: Maintenance treatment of opioid dependence	2/25/2013
Antara	Lupin Atlantis Holdings	Fenofibrate Capsules USP	Mylan Pharmaceuticals	reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and to reduce triglyceride levels in adult patients with severe hyper-triglyceridemia	2/25/2013
Malarone	GlaxoSmithKline	Atovaquone Proguanil	Glenmark Generics	prophylaxis and treatment of acute, uncomplicated plasmodium falciparum malaria	2/28/2013
Zometa	Novartis	Zoledronic Acid Injection	Dr. Reddy's Labs	hypercalcemia of malignancy	3/5/2013
Zometa	Novartis	Zoledronic Acid	Sagent Pharmaceuticals	hypercalcemia of malignancy, patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy	3/5/2013
Luvox CR	Jazz Pharmaceuticals	Fluvoxamine Maleate	Par Pharmaceutical	obsessive compulsive disorder	3/14/2013
Xopenex	Sunovion	Levalbuterol Inhalation Solution	Mylan Specialty	bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease	3/18/2013
Mucinex®	Reckitt Benckiser LLC	Guaifenesin Extended-Release	Perrigo	to relieve chest congestion and make coughs more productive	3/18/2013
Ortho Cyclen and Ortho Tri-Cyclen	Janssen	Norgestimate and Ethinyl Estradiol Tablets	Sandoz	oral contraceptives; treatment of moderate acne in women at least 15 yrs. of age who additionally desire an oral contraceptive for birth control	3/19/2013
Diovan HCT	Novartis	Valsartan and hydrochlorothiazide tablets	Lupin Pharmaceuticals	hypertension	3/22/2013
Accutane	Hoffman-LaRoche	Isotretinoin Capsules USP	Dr. Reddy's Labs	severe nodular acne	3/28/2013