Generic Launches

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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