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 |
|---|---|---|---|---|---|
| Avodart | GlaxoSmithKline | Dutasteride Capsules | Teva | indicated for the treatment of the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate | 10/12/2015 |
| Lescol XL | Novartis | Fluvastatin Sodium Extended-Release Tablets | Sandoz | indicated as an adjunctive therapy with changes to diet to lower cholesterol, slow the progression of heart disease, and reduce the risk of needing procedures to improve blood flow to the heart | 10/16/2015 |
| PhosLo Gelcaps | Fresenius Medical Care North America | Calcium Acetate Capsules | Lupin Pharms | indicated for control of hyperphosphatemia in end stage of renal failure | 10/26/2015 |
| Fusilev | Spectrum Pharms | Levoleucovorin Calcium Injection | Mylan | indicated for rescue use after high-dose methotrexate therapy in osteosarcoma; also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists | 10/27/2015 |
| Glucotrol XL | Pfizer | Glipizide Extended-Release Tablets | Mylan | indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | 11/16/2015 |
| Viramune XR | Boehringer Ingelheim | Nevirapine Extended-Release Tablets | Mylan | used in combination with other antiretroviral agents for treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age | 11/16/2015 |
| Axert | Janssen Pharms | Almotriptan Tablets | Mylan | used for the acute treatment of migraine attacks in adult patients with history of migraine with or without aura | 11/17/2015 |
| Adderall | Teva | Dextroamphetamine Saccharate / Amphetamine Aspartate / Dextroamphetamine Sulfate / Amphetamine Sulfate Tablets (mixed salts of a single entity amphetamine product) | Mylan | indicated for the treatment of attention deficit hyperactivity disorder (ADHD) | 11/19/2015 |
| FazaClo ODT | Jazz Pharm | Clozapine Orally Disintegrating Tablets | Mylan | treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment | 11/24/2015 |
| Zyvox | Pfizer | Linezolid Tablets | Mylan | treatment of certain infections caused by susceptible Gram-positive bacteria | 12/29/2015 |
