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