Generic Launches

Spring 2018

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Sustiva	Bristol-Myers Squibb	Efavirenz Capsules	Rising Pharms	indicated for the treatment of HIV-1 infection in adults and pediatric patients	1/2/2018
Estrace Cream	Allergan	Estradiol Vaginal Cream	Teva	indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause	1/2/2018
Busulfex	Otsuka	Busulfan Injection	Amneal	indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia	1/4/2018
Ancobon Capsules	Valeant Pharms	Flucytosine Capsules	Lupin	indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus	1/5/2018
Entocort EC	Perrigo Pharma	Budesonide Capsules	Amneal	used to help prevent the symptoms of asthma	1/18/2018
Ifex	Baxter	Ifosfamide Injection	West-Ward Pharms	indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis	1/18/2018
Vibra-Tabs Tablet	Pfizer	Doxycycline Hyclate Tablet	Lupin	indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne	1/19/2018
Epiduo Gel	Galderma Labs	Adapalene / Benzoyl Peroxide Gel	Perrigo	indicated for the topical treatment of acne vulgaris in patients 9 years of age and older	1/24/2018
Viread Tablets	Gilead Sciences	Tenofovir Disoproxil Fumarate Tablets	Cipla	indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older	1/29/2018
Viread Tablets	Gilead Sciences	Tenofovir Disoproxil Fumarate Tablets	Strides	indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and also indicated for the treatment of chronic hepatitis B in adults	1/29/2018
Accutane	Hoffmann-La Roche	Isotretinoin Capsules	Amneal	indicated for the treatment of severe recalcitrant nodular acne	2/1/2018
Clobex Lotion	Galderma Labs	Clobetasol Propionate Lotion	Lupin	is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, in patients 18 years of age or older	2/1/2018
Sustiva Tablets	Bristol-Myers Squibb	Efavirenz Tablets	Mylan	indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg	2/1/2018
Niaspan	AbbVie	Niacin ER Tablets	Aurobindo	indicated to reduce elevated TC, LDL-C, Apo B and TG and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia and to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia	2/2/2018
Xenazine	Valeant Pharms	Tetrabenazine Tablets	Dr. Reddy's Labs	indicated for the treatment of chorea associated with Huntington’s disease	2/2/2018
Concerta	Janssen	Methylphenidate HCl ER Tablets	Amneal	used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD)	2/5/2018
Tenormin	Alvogen	Atenolol Tablets	Rising Pharms	indicated for hypertension	2/7/2018
Kapvay Tablets	Concordia Int'l	Clonidine HCl ER Tablets	Lupin	indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications	2/8/2018
Syprine Capsules	Valeant Pharms	Trientine HCl Capsules	Teva	is used in the treatment of patients with Wilson’s disease who are intolerant of penicillamine	2/9/2018
Tamiflu Capsules	Hoffman-La Roche	Oseltamivir Phosphate Capsules	Lupin	is indicated for the treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours, and prophylaxis of influenza A and B in patients 1 year and older	2/12/2018
Viread Tablets	Gilead Sciences	Tenofovir Disoproxil Fumarate Tablets	Camber Pharms	used to treat Hepatitis B and HIV Infection	2/13/2018
Copaxone	Teva	Glatopa	Sandoz	indicated for the treatment of patients with relapsing-forms of multiple sclerosis	2/13/2018
Treximet	Pernix Ireland	Sumatriptan / Naproxen Sodium Tablets	Aurobindo	indicated for the acute treatment of migraine attacks with or without aura in adults	2/15/2018
Celexa	Forest Labs	Citalopram Oral Solution	Camber Pharms	used to treat depression	2/16/2018
Solodyn ER Tablets	Medicis Pharm	Minocycline HCl ER Tablets	Impax Labs	is used to treat moderate to severe acne in people 12 years and older	2/20/2018
Solodyn ER Tablets	Valeant Pharms	Minocycline HCl ER Tablets	Teva	indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older	2/20/2018
Namenda XR	Forest Labs	Memantine HCl ER Capsules	Amneal	used to treat moderate to severe Alzheimer's type dementia	2/21/2018
Namenda XR Capsules	Allergan	Memantine HCl ER Capsules	Lupin	indicated for the treatment of moderate to severe dementia of the Alzheimer’s type	2/21/2018
Axiron Topical Solution	Eli Lilly	Testosterone Topical Solution	Lupin	indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone	2/26/2018
Zantac (OTC)	Sanofi	Ranitidine Tablets (OTC)	Strides	used to treat peptic ulcers of the stomach and intestines and gastroesophageal reflux and heartburn related to indigestion	2/26/2018
Ritalin LA Capsules	Novartis	Methylphenidate ER Capsules	Mayne Pharma	indicated for Attention Deficit Hyperactivity Disorder (ADHD)	2/28/2018
Tamiflu	Hoffman La Roche	Oseltamivir Phosphate for Oral Suspension	Amneal	used for treating and preventing the flu	3/1/2018
Tamiflu	Hoffman La Roche	Oseltamivir Phosphate Capsules	Camber Pharms	used for treating and preventing the flu	3/8/2018
Gabitril	Cephalon	Tiagabine HCl Tablets	Amneal	used in the treatment of epilepsy	3/12/2018
Safyral Tablets	Bayer Healthcare	Tydemy Tablets	Lupin	indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception	3/13/2018
Sustiva Tablets	Bristol-Myers Squibb	Efavirenz Tablets	Strides	indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults and adolescents	3/14/2018
Monodox	Aqua Pharms	Doxycycline Monohydrate IR Capsules	Mayne Pharma	indicated for the treatment of a number of infections, including adjunctive therapy in severe acne	3/15/2018
Xyzal Allergy 24HR Tablets (OTC)	Sanofi-Aventis	Levocetirizine Dihydrochloride Tablets (OTC)	Dr. Reddy's Labs	used for 24-hour relief of allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing	3/16/2018
Mutamycin	Bristol-Myers Squibb	Mitomycin for Injection	Mylan	used in combination with other cancer medicines in the treatment of stomach and pancreatic cancers	3/20/2018
Norvir Tablets	AbbVie	Ritonavir Tablets	West-Ward Pharms	for use in combination with other antiretroviral agents for treatment of human immunodeficiency virus (HIV-1) infection	3/20/2018
Aloxi	Helsinn Healthcare	Palonosetron HCl Injection	Teva	indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy and for prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy	3/23/2018
Aloxi	Helsinn	Palonosetron HCl Injection	Cipla	indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy and for prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy	3/26/2018
Aloxi	Helsinn Healthcare	Palonosetron HCl Injection	Dr. Reddy's Labs	indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy and for prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy	3/26/2018
Lodosyn Tablets	Aton Pharma	Carbidopa Tablets	Lupin	indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication	3/26/2018
Quartette	Teva	Levonorgestrel / Ethinyl Estradiol Tablets / Ethinyl Estradiol Tablets	Mayne Pharma	indicated for the prevention of pregnancy	3/26/2018
Lialda	Nogra Pharma	Mesalamine DR Tablets	Teva	indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis	3/26/2018
Baraclude Tablets	Bristol-Myers Squibb	Entecavir Tablets	Breckenridge	for the treatment of chronic hepatitis B virus infection in adults and children at least 2 year of age	3/27/2018
Clobex Spray	Galderma Labs	Clobetasol Propionate Spray	Lupin	indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older	3/29/2018
Motrin Oral Suspension	Johnson and Johnson / McNeil Consumer Healthcare	Ibuprofen Oral Suspension	Aurobindo	indicated for the reduction of fever, to relieve pain and to relieve the signs and symptoms of juvenile arthritis in pediatric patients. In adult patients, for the treatment of primary dysmenorrhea and to relieve signs and symptoms of rheumatoid arthritis and osteoarthritis