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Generic Launches

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

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