Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Abbreviated New Drug Applications and 505(b)(2) Applications
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.
| Reference Listed Drug | ANDA 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 |
