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
EpivirÂ	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