Generic Launches

Fall 2017

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Focalin XR	Novartis	Dexmethylphenidate HCl ER Capsules	Impax Laboratories	used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older	7/5/2017
Vigamox	Novartis	Moxifloxacin HCl Solution	Lupin	used for the treatment of bacterial conjunctivitis caused by susceptible strains of the organisms	7/5/2017
Axiron	Eli Lilly	Testosterone Topical Solution	Perrigo	used for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone	7/5/2017
Concerta	Janssen	Methylphenidate HCl ER Tablets	Impax Laboratories	used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older	7/17/2017
Renvela	Genzyme	Sevelamer Carbonate Tablets	Aurobindo Pharma USA	used for the control of serum phosphorus in patients with chronic kidney disease	7/19/2017
Altace	Pfizer	Ramipril Capsules	Rising Pharmaceuticals	used for the treatment of hypertension	7/21/2017
Cozaar	Merck	Losartan Potassium Tablets	Rising Pharmaceuticals	used for the treatment of hypertension	7/21/2017
Hyzaar	Merck	Losartan Potassium / Hydrochlorothiazide Tablets	Rising Pharmaceuticals	used for the treatment of hypertension	7/21/2017
Pravachol	Bristol-Myers Squibb	Pravastatin Tablets	Rising Pharmaceuticals	used as an adjunct to diets restricting saturated fats and cholesterol	7/21/2017
Temodar	Schering	Temozolomide Capsules	Rising Pharmaceuticals	used for the treatment of adult patients with newly diagnosed glioblastoma multiforme	7/21/2017
Zomig-ZMT	AstraZeneca	Zolmitriptan Orally Disintegrating Tablets	Rising Pharmaceuticals	used for the acute treatment of migraines	7/21/2017
Cetirizine HCl Capsules (Softgel) (OTC)	Bionpharma	Cetirizine HCl Capsules (Softgel) (OTC)	Strides Shasun	used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives and itching	7/24/2017
Vagifem	Novo Nordisk	Estradiol Vaginal Inserts	Teva	used for the treatment of atrophic vaginitis due to menopause	7/24/2017
Robinul	Shionogi	Glycopyrrolate Tablets	Heritage Pharmaceuticals	used for adjunctive therapy in the treatment of peptic ulcer	7/25/2017
Wellburin	GlaxoSmithKline	Bupropion Tablets	Heritage Pharmaceuticals	used for the treatment of depression	7/25/2017
Epiduo	Galderma Laboratories	Adapalene / Benzoyl Peroxide Gel	Teva	used for the topical treatment of acne vulgaris in patients 9 years of age and older	7/28/2017
Transderm Scop	Sandoz	Scopolamine 1.5 mg Transdermal System Patch	Perrigo	used for the prevention of nausea and vomiting associated with motion sickness and recovery from anesthesia after surgery in adults	7/31/2017
Tamiflu	Roche	Oseltamivir Phosphate Capsules	Amneal	used to treat and prevent influenza A and influenza B (flu)	8/8/2017
Roxicodone	Mallinckrodt	Oxycodone HCI Tablets	Camber Pharmaceuticals	used to help relieve moderate to severe pain	8/17/2017
Ziagen	ViiV Healthcare	Abacavir Oral Solution	Camber Pharmaceuticals	used in combination with other antiretroviral agents for the treatment of HIV-1 infection	8/17/2017
Axiron	Eli Lilly	Testosterone Topical Solution	Teva	used to treat adult males who have low or no testosterone due to certain medical conditions	8/18/2017
Seroquel XR	AstraZeneca	Quetiapine Fumarate ER Tablets	Lupin	used for the treatment of schizophrenia; acute manic or mixed episodes in bipolar I disorder alone or as an adjunct to lithium or divalproex; acute depressive episodes in bipolar disorder; maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder	8/23/2017
Suprax	Astellas	Cefixime for Oral Suspension	Dr. Reddy's Laboratories	used in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria: Uncomplicated Urinary Tract Infections; Otitis Media; Pharyngitis and Tonsillitis; Acute Exacerbations of Chronic Bronchitis; Uncomplicated Gonorrhea (cervical/urethral)	8/28/2017
Sabril	Lundbeck	Vigabatrin for oral solution	Endo	used with other treatments in adults and children 10 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments and if the possible benefits outweigh the risk of vision loss	8/28/2017
Relpax	Pfizer	Eletriptan Hydrobromide Tablets	Ajanta	used to treat migraines	8/31/2017
Fosrenol	Shire	Lanthanum Carbonate Chewable Tablets	Lupin	used to reduce serum phosphate in patients with end stage renal disease (ESRD)	8/31/2017
Oxycodone HCl	Lehigh Valley	Oxycodone HCl Tablets	ANI Pharmaceuticals	used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	9/1/2017
Benicar	Daiichi Sankyo	Olmesartan Medoxomil Tablets	Lupin	used for the treatment of hypertension, alone or in combination with other antihypertensive agents, to lower blood pressure	9/4/2017
Skelaxin	King Pharmaceuticals	Metaxalone Tablets	Dr. Reddy's Laboratories	used as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions	9/6/2017
Wellbutrin XL	GlaxoSmithKline	Bupropion HCl ER Tablets	Dr. Reddy's Laboratories	used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder)	9/6/2017
Cancidas	Merck	Caspofungin Acetate for Injection	Fresenius Kabi USA	used in adults and pediatric patients (3 months of age and older) 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	9/12/2017
Urocit-K	Mission Pharma	Potassium Citrate ER Tablets	Strides Shasun	used for preventing certain types of kidney stones	9/12/2017
Symmetrel	Upsher-Smith	Amantadine HCl IR Capsules	Heritage Pharmaceuticals	used for the treatment of influenza A virus infection and is also used in the treatment of Parkinson's	9/14/2017
Minastrin 24 FE	Allergan	Norethindrone Acetate / Ethinyl Estradiol Tablets / Ferrous Fumarate Tablets	Mylan	used for use by women to prevent pregnancy	9/14/2017
Lovaza	SmithKline Beecham	Omega-3-Acid Ethyl Esters Capsules	Strides Shasun	used as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG)	9/20/2017
Nexium 24HR (OTC)	AstraZeneca	Esomeprazole Magnesium (OTC)	Perrigo	used to treat frequent heartburn (occurring 2 or more days a week)	9/27/2017
Minastrin 24 FE	Allergan	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Capsules	Amneal	used for use by women to prevent pregnancy	9/28/2017
Renvela	Genzyme Corp	Sevelamer Carbonate Tablets	Dr. Reddy's Laboratories	used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis	9/29/2017
Gleevec	Novartis	Imatinib Mesylate Tablets	Mylan	used in newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, etc.	9/29/2017