| 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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