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Generic Launches

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

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