| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Diamox | Teva | Acetazolamide IR Tablets | Heritage Pharmaceuticals | indicated for the treatment of glaucoma, epilepsy, mountain sickness and fluid retention | 1/4/2017 |
| Emend | Merck Sharp & Dohme | Aprepitant Capsules | Sandoz | prescribed for patients 12 years of age or older, in combination with other antiemetic agents to help prevent nausea and vomiting caused by certain chemotherapy medicines and for adults to prevent nausea and vomiting after surgery | 1/4/2017 |
| MS Contin ER | Purdue Pharma | Morphine Sulfate ER Tablets | Lupin | indicated for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate | 1/13/2017 |
| Pacerone | Upsher-Smith Laboratories | Amiodarone Tablets | Mayne Pharma | indicated for life-threatening recurrent ventricular arrhythmia | 1/13/2017 |
| Ortho-Cyclen 28 | Janssen | Norgestimate / Ethinyl Estradiol Tablets | Lupin | indicated for use by females of reproductive potential to prevent pregnancy | 1/24/2017 |
| Lotronex | Promethius Laboratories | Alosetron Hydrochloride Tablets | Amneal Pharmaceuticals | indicated for women with severe diarrhea-predominant irritable bowel syndrome (IBS) | 1/30/2017 |
| Integrilin | Merck | Eptifibatide Injection | Amneal Pharmaceuticals | used to prevent blood clots or heart attack in people with severe chest pain or other conditions, and in those who are undergoing a procedure called angioplasty (to open blocked arteries) | 1/31/2017 |
| Imdur | Schering | Isosorbide Mononitrate ER Tablets | Heritage Pharmaceuticals | indicated for the prevention of angina pectoris due to coronary artery disease | 1/31/2017 |
| Versed | Hoffman-La Roche | Midazolam Injection | Heritage Pharmaceuticals | used as an agent for preoperative sedation | 1/31/2017 |
| Tricor | AbbVie | Fenofibrate Tablets | Camber Pharmaceuticals | reduce cholesterol and triglycerides in the blood | 2/1/2017 |
| Bupap | ECR Pharmaceuticals | Butalbital Acetaminophen (APAP) Tablets | Mayne Pharma | indicated for treatment of tension headache (migraine) | 2/16/2017 |
| Ritalin LA | Novartis | Methylphenidate ER Capsules | Mayne Pharma | indicated for attention deficit hyperactivity disorder (ADHD) | 2/21/2017 |
| Pristiq | Pfizer | Desvenlafaxine Succinate ER Tablets | Breckenridge | indicated for treatment of major depressive disorder (MDD) | 3/1/2017 |
| Temovate | Fougera Pharmaceuticals | Clobetasol Propionate Scalp Application | Lupin | indicated for short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp | 3/1/2017 |
| Pristiq ER | Pfizer | Desvenlafaxine ER Tablets | Teva | indicated for treatment of major depressive disorder (MDD) | 3/1/2017 |
| Pristiq | Wyeth | Desvenlafaxine Succinate ER Tablets | Lupin | indicated for the treatment of major depressive disorder (MDD) | 3/2/2017 |
| Paxil CR | Apotex | Paroxetine ER Tablets | Lupin | treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder | 3/7/2017 |
| Women's Rogaine 5% Minoxidil Foam (OTC) | Johnson & Johnson | Store Brand Equivalent to Women's Rogaine Foam (OTC) | Perrigo | indicated to regrow hair on the top of the scalp | 3/8/2017 |
| Hydrocodone Bitartrate / Acetaminophen Tablets | Mikart | Hydrocodone Bitartrate / Acetaminophen Tablets | Lupin | indicated for the relief of moderate to moderately severe pain | 3/9/2017 |
| Pristiq | Wyeth | Desvenlafaxine Succinate ER Tablets | Hikma | indicated for the treatment of major depressive disorder (MDD) | 3/10/2017 |
| Pristiq | Pfizer | Desvenlafaxine ER Tablets | Mylan | indicated for the treatment of major depressive disorder (MDD) | 3/10/2017 |
| Aromasin | Pfizer | Exemestane Tablets | Mylan | indicated in the treatment of certain types of breast cancer in women after menopause | 3/13/2017 |
| Minastrin 24 Fe | Allergan | Ferrous Fumarate Tablets | Lupin | indicated for use by females of reproductive age to prevent pregnancy | 3/16/2017 |
| Minastrin 24 Fe | Allergan | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Tablets | Teva | indicated for use by women to prevent pregnancy | 3/16/2017 |
| TOBI | Novartis | Tobramycin Inhalation Solution | Lupin | indicated for the management of cystic fibrosis patients with P. aeruginosa | 3/23/2017 |
| Eliphos | Hawthorn Pharmaceuticals | Calcium Acetate IR Tablets | Heritage Pharmaceuticals | indicated to reduce serum phosphorus in patients with end stage renal disease | 3/27/2017 |
| Xeloda | Hoffman La Roche | Capecitabine Tablets | ACETO | indicated for the treatment of metastatic breast cancer | 3/28/2017 |
| Fusilev | Spectrum Pharmaceuticals | Levoleucovorin for Injection | Amneal Biosciences | is a foliate analog indicated for rescue after high-dose methotrexate therapy for osteosarcoma and diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent over dosage of folic acid antagonists | 3/28/2017 |
| Merrem | AstraZeneca | Meropenem Injection | Aurobindo Pharma USA | indicated as single agent therapy for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections such as appendicitis and peritonitis, and bacterial meningitis | 3/28/2017 |
| Epzicom | VIIV Healthcare | Abacavir / Lamivudine Tablets | Lupin | indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection | 3/29/2017 |
| Epizcom | VIIV Healthcare | Abacavir Sulfate / Lamivudine Tablets | Aurobindo Pharma USA | indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection | 3/30/2017 |
| Zyflo CR | Chiesi USA | Zileuton ER Tablets | ACETO | indicated for the chronic treatment of asthma | 3/31/2017 |
