Generic Launches

Summer 2018

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Ellence	Pfizer	Epirubicin HCl Injection	West-Ward Pharmaceuticals	indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer	4/5/2018
Estrace Cream	Allergan	Estradiol Vaginal Cream	Impax / Perrigo	used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning and irritation vaginal dryness and inflammation	4/6/2018
Aloxi	Helsinn Healthcare	Palonosetron HCl Injection	Fresenius Kabi USA	indicated in adults for moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses	4/11/2018
Prilosec	Procter & Gamble	Omeprazole DR Orally Disintegrating Tablets (OTC)	Perrigo	treat frequent heartburn	4/11/2018
Cubicin	Cubist Pharms	Daptomycin for Injection	Fresenius Kabi USA	indicated for the treatment of: Complicated skin and skin structure infections (CSSSI) in adult patients; Staphylococcus aureus bloodstream infections (bacteremia) in adult patients, including those with right-sided infective endocarditis	4/12/2018
Alkeran	Apotex	Melphalan HCl for Injection	Fresenius Kabi USA	indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate	4/16/2018
Cordarone	Sanofi	Amiodarone Tablets	Mayne Pharma	indicated for life-threatening recurrent ventricular arrhythmia	4/16/2018
Zinecard	Pharmacia and Upjohn	Dexrazoxane for Injection	West-Ward Pharmaceuticals	is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in certain women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control	4/20/2018
Yaz	Bayer	Drospirenone / Ethinyl Estradiol Tablets	Mylan	indicated for use by women to prevent pregnancy and for the treatment of acne vulgaris in women at least 14 years of age who have achieved menarche and desire an oral contraceptive for birth control	4/24/2018
Methylin	Mallinckrodt	Methylphenidate Chewable tablets	Camber Pharmaceuticals	is used to treat attention deficit hyperactivity disorder- ADHD	4/30/2018
Sabril	Lundbeck Pharms	Vigabatrin for Oral Solution	Amneal	indicated as adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss	5/2/2018
Sustiva	Bristol-Myers Squibb	Efavirenz Tablets	Camber Pharmaceuticals	used to treat HIV	5/2/2018
Opana	Endo Pharmaceuticals	Oxymorphone Tablets	Camber Pharmaceuticals	used to treat moderate to severe pain	5/4/2018
Zovirax	GlaxoSmithKline	Acyclovir Capsules	Heritage Pharmaceuticals	indicated for the treatment of herpes zoster, genital herpes and chickenpox	5/14/2018
Amidate	Hospira	Etomidate Injection	Heritage Pharmaceuticals	indicated for the induction of general anesthesia	5/14/2018
Mephyton	Valeant	Phytonadione Tablets	Amneal	is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces	5/15/2018
Welchol	Daiichi Sankyo	Colesevelam HCI	Amneal	is a lipid-lowering and glucose-lowering agent used to lower "bad" cholesterol in the blood	5/17/2018
Welchol	Daiichi Sankyo	Colesevelam HCl	Sun Pharmaceutical	is a lipid-lowering and glucose-lowering agent used to lower "bad" cholesterol in the blood	5/17/2018
Welchol	Daiichi Sankyo	Colesevelam HCl	Glenmark Generics	is a lipid-lowering and glucose-lowering agent used to lower "bad" cholesterol in the blood	5/21/2018
Methergine	Lupin	Methylergonovine Maleate Tablets	West-Ward Pharmaceuticals	indicated for the prevention and control of postpartum hemorrhage	5/30/2018
Provigil	Cephalon	Modafinil Tablets	Heritage Pharmaceuticals	indicated for the treatment of disorders such as narcolepsy, shift work sleep disorder and obstructive sleep apnea	6/1/2018
Methergine	Novartis	Methylergonovine Maleate Tabs	Lupin	indicated for the prevention and control of postpartum hemorrhage	6/4/2018
Viagra	Pfizer	Sildenafil Tablets	Camber Pharmaceuticals	treat erectile dysfunction (impotence) in men	6/11/2018
Tobi	Novartis	Tobramycin Inhalation Solution	Lupin	indicated for the management of cystic fibrosis patients with P. aeruginosa	6/13/2018
Suboxone	Indivior	Buprenorphine HCl / Naloxone HCl Sublingual Film	Dr. Reddy's Laboratories	used to treat adults with opioid dependence/addiction	6/15/2018
Angiomax	The Medicines Company	Bivalirudin for Injection	Mylan	indicated for use as an anticoagulant in patients	6/18/2018
Viagra	Pfizer	Sildenafil Citrate Tablets	Aurobindo	treat erectile dysfunction (impotence) in men	6/19/2018
Sustiva	Bristol-Myers Squibb	Efavirenz Tablets	Cipla	is 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	6/19/2018
Levetiracetam in Sodium Chloride Injection	HQ Specialty Pharma	Levetiracetam in Sodium Chloride Injection	Dr. Reddy's Laboratories	is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy	6/19/2018
Depo-Testosterone	Pharmacia and Upjohn	Testosterone Cypionate for Injection	Cipla	is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone	6/21/2018
Reyataz	Bristol-Myers Squibb	Atazanavir Capsules	Aurobindo	indicated for use in combination with other antiretroviral agents for the treatment of HIV infection	6/25/208