Generic Launches

Fall 2018

GENERICally Speaking
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
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