Generic Launches

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

April 16, 2013

GENERICally Speaking
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
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

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