| 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 |
