Generic Launches

Winter 2017

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