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Generic Launches
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Fall 2014
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 |
GENERICally Speaking Winter 2014
Related Publications
September 18, 2024
Astellas Pharma, Inc. v. Sandoz Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 9, 2024
Purdue Pharma L.P v. Accord Healthcare Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 4, 2024
Exeltis USA, Inc. v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
August 28, 2024
Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S.
GENERICally Speaking Hatch Waxman Bulletin
August 13, 2024
Allergan USA, Inc. v. MSN Labs. Private Ltd.
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