Generic Launches

Fall 2018

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Colcrys	Takeda	Colchicine Tablets	Endo	indicated for prophylaxis and treatment of gout flares in adults and Familial Mediterranean Fever (FMF) in adults and children 4 years or older	7/2/2018
Exelon Patch	Novartis	Rivastigmine Transdermal System	Mylan	indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer's Disease and the treatment of mild to moderate dementia associated with Parkinson's Disease	7/9/2018
Uceris	Santarus and Valeant Pharmaceuticals	Budesonide Extended-Release Tablets	Teva	indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis	7/9/2018
Plaquenil	Concordia	Hydroxychloroquine Sulfate Tablets	Dr. Reddy's Labs	indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported; the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; the treatment of acute and chronic rheumatoid arthritis in adults	7/11/2018
Kapvay	Concordia	Clonidine Extended-Release Tablets	Mayne Pharma	indicated for the treatment of attention deficit hyperactivity disorder as monotherapy or as adjunct to stimulant medications	7/16/2018
Blenoxane	Bristol-Myers Squibb	Bleomycin for Injection	Hikma	indicated for the management of certain types of Squamous Cell Carcinoma, Lymphomas, Testicular Carcinoma, and Malignant Pleural Effusion	7/18/2018
Nexium 24HR Capsules	AstraZeneca	Esomeprazole Magnesium Delayed-Release Capsules	Dr. Reddy's Labs	indicated for the treatment of frequent heartburn occurring two or more days a week in adults	7/20/2018
Potassium Chloride Oral Solution	Genus LifeSciences	Potassium Chloride Oral Solution	Amneal	indicated for the treatment or prevention of low levels of potassium in the blood	7/23/2018
Efudex	ICN Pharmaceuticals	Fluorouracil Cream	Mayne Pharma	indicated for the treatment of multiple actinic or solar keratoses, and for the treatment of superficial basal cell carcinomas when conventional methods of treatment are impractical	7/23/2018
Glumetza HCI ER Tablets	Santarus	Metformin HCl Extended-Release Tablets	Sun	indicated for the treatment of patients with type 2 diabetes; controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems	7/25/2018
Invanz	Merck Sharpe & Dohme	Ertapenem for Injection	Endo	indicated for the treatment of infections and it can also prevent infections after colon and rectal surgery	7/27/2018
Topicort Topical Spray	Taro	Desoximetasone Topical Spray	Lupin	indicated for the treatment of plaque psoriasis in patients 18 years of age or older	7/27/2018
Voltaren Gel	GlaxoSmithKline	Diclofenac Sodium Topical Gel, 1%	Cipla	indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands	8/7/2018
Xeloda	Genentech	Capecitabine	MSN Labs / Cipla	indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred, and also indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy	8/10/2018
Adcirca	Eli Lilly	Tadalafil Tablets	Mylan	indicated for the treatment of pulmonary arterial hypertension to improve exercise ability	8/13/2018
Temovate	Fougera Pharmaceuticals	Clobetasol Propionate Cream	Lupin	indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses	8/21/2018
Beyaz	Bayer	Drospirenone / Ethinyl Estradiol / Levomefolate Calcium Tablets	Lupin	indicated for the treatment as an oral contraceptive for birth control	8/27/2018
Klor-Con ER Tablets	Upsher-Smith Labs	Potassium Chloride Extended-Release Tablets	Strides	indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis	9/5/2018
Bloxiverz	Avadel Legacy Pharmaceuticals	Neostigmine Methylsulfate Injection	Dr. Reddy's Labs	indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery	9/12/2018
Brevibloc	Baxter	Esmolol HCl in Sodium Chloride Injection	Mylan	indicated for the short-term treatment of control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia and control of perioperative tachycardia and hypertension	9/13/2018
Ampyra	Acorda	Dalfampridine Extended-Release Tablets	Mylan	indicated to improve walking in adult patients with multiple sclerosis	9/13/2018
Norvir	AbbVie	Ritonavir Tablets	Camber Pharmaceuticals	indicated for the treatment of HIV	9/18/2018
Albenza	Impax Labs	Albendazole Tablets	Cipla	indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia sodium and cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus	9/22/2018
Cialis	Eli Lilly	Tadalafil Tablets	Teva	indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH (ED/BPH)	9/27/2018