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 |
|---|---|---|---|---|---|
| Combivir | ViiV Healthcare | Lamivudine and Zidovudine Tablets USP | Mylan | treatment of HIV-1 infection in combination with other antiretroviral (ARV) agents | 10/3/2014 |
| Precedex | Hospira | Dexmedetomidine Hydrochloride | Sandoz | sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and the sedation of non-intubated patients prior to and/or during surgical and other procedures | 10/6/2014 |
| Rapamune | Wyeth | Sirolimus Tablets | Dr. Reddy's Labs. | prophylaxis of organ rejection in patients aged ≥ 13 years receiving renal transplants |
10/27/2014 |
| Viramune XR | Boehringer Ingelheim | Nevirapine Extended-Release Tablets | Mylan | for combination antiretroviral (ARV) treatment of HIV-1 infection in adults and in children 6 to < 18 years of age | 10/30/2014 |
| Prilosec | AstraZeneca | Omeprazole Delayed-Release Capsules | Glenmark Generics | short-term treatment of active duodenal ulcer in adults | 11/5/2014 |
| Zemplar | AbbVie | Paricalcitol Injection | Hospira | prevention and treatment of secondary hyperparathyroidism associated with Stage 5 Chronic Kidney Disease (CKD) | 11/5/2014 |
| Loestrin 24 Fe | Warner Chilcott | Norethindrone Acetate / Ethinyl Estradiol Tablets and Ferrous Fumarate | Mylan | prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception | 11/5/2014 |
| Antara | Lupin Atlantis | Fenofibrate Capsules | Ranbaxy Labs. | for primary hypercholesterolemia and mixed dyslipidemia | 11/5/2014 |
| Cytoxan | Baxter Healthcare | Cyclophosphamide Injection | Sandoz | chemotherapy agent to treat certain types of cancer in adults and pediatric patients | 11/10/2014 |
| Activella | Novo Nordisk | Estradiol / Norethindrone Acetate Tablets | Amneal Pharms. | treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis | 11/20/2014 |
| Allegra-D | Aventisub II | Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride Extended-Release Tablets | Dr. Reddy's Labs. | allergy and nasal congestion | 11/20/2014 |
| Valcyte | Hoffman-La Roche | Valganciclovir Tablets | Endo Pharms. | treatment of cytomegalovirus (CMV) disease | 11/20/2014 |
| Taxotere | Aventis Pharma | Docetaxel Injection USP | Dr. Reddy's Labs. | microtubule inhibitor indicated for the treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck cancer | 11/24/2014 |
| Protopic Ointment | Astellas U.S. | Tacrolimus | Perrigo | treat moderate to severe eczema | 11/24/2014 |
| Intuniv | Shire | Guanfacine Hydrochloride | Actavis | treat Attention Deficit Hyperactivity Disorder in patients ages 6 to 17 | 12/1/2014 |
| Exforge HCT | Novartis Pharms. | Amlodipine / Valsartan / Hydrochlorothiazide Tablets | Teva | treatment of hypertension to lower blood pressure | 12/1/2014 |
| Pennsaid | Mallinckrodt | Diclofenac Sodium Topical Solution 1.5% w/w | Perrigo | treatment of signs and symptoms of osteoarthritis of the knee(s) | 12/2/2014 |
| Celebrex | Pfizer | Celecoxib Capsules | Actavis | relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults | 12/10/2014 |
| Celebrex | G.D. Searle | Celecoxib Capsules | Lupin Pharms. | relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults | 12/11/2014 |
| Orapred ODT | Shionogi | Prednisolone Sodium Phosphate Orally-Disintegrating Tablets | Mylan | an anti-inflammatory or immunosuppressive agent for certain conditions; and also for the treatment of certain endocrine conditions, and for palliation of certain neoplastic conditions | 12/11/2014 |
| Robaxin | Hikma Maple | Methocarbamol Injection | Mylan | adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions | 12/11/2014 |
| Valcyte | Hoffman-La Roche | Valganciclovir Tablets | Dr. Reddy's Labs. | treatment of cytomegalovirus (CMV) disease | 12/16/2014 |
| Vivelle-Dot | Novartis Pharms. | Estradiol Transdermal System USP | Mylan | treatment of certain menopausal symptoms and for the prevention of postmenopausal osteoporosis | 12/22/2014 |
| Vivelle-Dot | Novartis Pharms. | Estradiol Transdermal System | Sandoz | treatment of certain menopausal symptoms and for the prevention of postmenopausal osteoporosis | 12/22/2014 |
| Epivir | ViiV Healthcare | Lamivudine Tablets | Lupin Pharms. | treatment of human immunodeficiency virus (HIV-1) infection | 12/26/2014 |
| Coly-Mycin M | Par Sterile Products | Colistimethate Sodium | Sagent Pharms. | treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli | 12/30/2014 |
