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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Kapvay Concordia Pharmaceuticals Clonidine HCl ER Tablets Ajanta used to treat attention deficit hyperactivity disorder (ADHD) 11/21/2017
Tamiflu Hoffman La-Roche Oseltamivir Phosphate Alvogen used to treat the flu (Influenza) in people 2 weeks of age and older who have had flu symptoms for no more than 2 days. Tamiflu can also reduce the chance of getting the flu in people 1 year and older 11/2/2017
Clolar Genzyme Clofarabine Injection Amneal used to treat pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens 11/28/2017
Kenalog-40 Apothecon Triamcinolone Acetonide Injectable Suspension Amneal used to treat inflammation (swelling), allergic reactions, certain types of arthritis, gout, skin diseases, and many other medical problems 12/19/2017
Renvela Genzyme Sevelamer Carbonate Tablets Amneal used to control serum phosphorus in adults with chronic kidney disease (CKD) on dialysis 12/19/2017
Prometrium Virtus Pharms Progesterone Capsules Amneal used to prevent endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea 12/19/2017
Bumex Validus Pharms Bumetanide Tablets Amneal used to treat edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome 12/19/2017
Vytorin Merck Sharp & Dohme Ezetimibe / Simvastatin Tablets Amneal  used to treat high cholesterol and triglyceride (fats) levels in the blood 12/19/2017
Kapvay Concordia Pharms Clonidine HCl ER Tablets Amneal used to treat attention deficit hyperactivity disorder (ADHD) 12/19/2017
Busulfex Otsuka Myleran Injecion Mylan used in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia 12/4/2017
Zetia Merck Sharp & Dohme Ezetimibe Tablets Aurobindo used as adjunctive therapy for the reduction of elevated total cholesterol 10/11/2017
Effient Eli Lilly Prasugrel Tablets Aurobindo used to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) 10/30/2017
Seroquel XR AstraZeneca Quetiapine Fumarate ER Tablets Aurobindo used to treat schizophrenia, manic or mixed episodes associated with bipolar I disorder and as an adjunct therapy to antidepressants for the treatment of major depressive disorder (MDD) 12/1/2017
Megace ES Endo Megestrol Acetate Oral Suspension Breckenridge used to treat anorexia (loss of appetite), cachexia (severe malnutrition), or an unexplained, significant weight loss in people with a diagnosis of AIDS 12/4/2017
Renvela Genzyme Sevelamer Carbonate Tablets InvaGen Pharmaceuticals used to control serum phosphorus in adults with chronic kidney disease (CKD) on dialysis 10/27/2017
Pulmicort Respules AstraZeneca Budesonide Inhalation Suspension Cipla used for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age 11/17/2017
Dacogen Otsuka Decitabine Injection Cipla used to treat patients with myelodysplastic syndromes (MDS). 11/20/2017
Clolar Genzyme Clofarabine Injection Dr. Reddy's Labs used to treat patients ages 1 year to 21 years with relapsed or refractory acute lymphoblastic leukemia after at least two prior treatment regimens 11/14/2017
Alkeran Apotex Melphalan HCl for Injection Dr. Reddy's Labs used for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate 12/26/2017
Emend Merck Sharp & Dohme Aprepitant Capsules Glenmark  used in adults for the prevention of postoperative nausea and vomiting 10/16/2017
Ancobon Valeant Flucytosine Capsules West-Ward Pharms used to treat serious infections caused by susceptible strains of candida and/or cryptococcus 11/3/2017
Renvela Genzyme Sevelamer Carbonate Tablets Impax Labs used to control serum phosphorus in adults with chronic kidney disease (CKD) on dialysis 10/23/2017
Norco Allergan Hydrocodone Bitartrate / Acetaminophen Tablets Lupin used for relief of moderate or moderately severe pain 10/10/2017
Acticlate Aqua Pharmaceuticals Doxycycline Hyclate Tablets  Lupin used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne 11/2/2017
Clozaril Novartis  Clozapine Tablets Mayne Pharma used as an antipsychotic 11/9/2017
Cancidas Merck Caspofungin Acetate for Injection Mylan used for empirical therapy for presumed fungal infections in febrile, neutropenic patients; treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections; treatment of esophageal candidiasis; and treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies 10/2/2017
Copaxone Teva Glatiramer Acetate Injection Mylan used for the treatment of people with relapsing forms of Multiple Sclerosis (MS) 10/4/2017
Avelox Bayer Moxifloxacin HCl in 0.8% Sodium Chloride Injection Mylan used to treat infections in adults caused by designated susceptible bacteria in community acquired pneumonia, skin and skin structure infections, complicated intra-abdominal infections, plague, acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis 10/5/2017
Clolar Genzyme Clofarabine Injection Mylan used to treat pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens 11/9/2017
Estrace Allergan Estradiol Vaginal Cream Mylan used to treat vulvar and vaginal atrophy 12/29/2017
Exalgo ER Mallinckrodt Hydromorphone HCl ER Tablets Perrigo used for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time 11/27/2017
Mycolog II Mylan Nystatin / Triamcinolone Acetonide Cream Perrigo used to treat cutaneous candidiasis 11/27/2017
Zoloft Pfizer Sertraline Oral Solution Rising Pharmaceuticals used to treat the following: major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder 10/24/2017
Diamox Teva Acetazolamide Strides
used to prevent and reduce the symptoms of altitude
sickness. Acetazolamide is also used with other medications to treat a certain type of
eye problem (open-angle glaucoma)
11/22/2017
Viagra Pfizer Sildenafil Citrate Teva used to treat erectile dysfunction (ED) 12/11/2017
Viread Gilead Sciences Tenofovir Disoproxil Fumarate Teva used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older, and for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older 12/15/2017
Reyataz Bristol-Myers Squibb Atazanavir Teva used in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg 12/27/2017

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