| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Ellence | Pfizer | Epirubicin HCl Injection | West-Ward Pharmaceuticals | indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer | 4/5/2018 |
| Estrace Cream | Allergan | Estradiol Vaginal Cream | Impax / Perrigo | used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning and irritation vaginal dryness and inflammation | 4/6/2018 |
| Aloxi | Helsinn Healthcare | Palonosetron HCl Injection | Fresenius Kabi USA | indicated in adults for moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses | 4/11/2018 |
| Prilosec | Procter & Gamble | Omeprazole DR Orally Disintegrating Tablets (OTC) | Perrigo | treat frequent heartburn | 4/11/2018 |
| Cubicin | Cubist Pharms | Daptomycin for Injection | Fresenius Kabi USA | indicated for the treatment of: Complicated skin and skin structure infections (CSSSI) in adult patients; Staphylococcus aureus bloodstream infections (bacteremia) in adult patients, including those with right-sided infective endocarditis | 4/12/2018 |
| Alkeran | Apotex | Melphalan HCl for Injection | Fresenius Kabi USA | indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate | 4/16/2018 |
| Cordarone | Sanofi | Amiodarone Tablets | Mayne Pharma | indicated for life-threatening recurrent ventricular arrhythmia | 4/16/2018 |
| Zinecard | Pharmacia and Upjohn | Dexrazoxane for Injection | West-Ward Pharmaceuticals | is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in certain women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control |
4/20/2018 |
| Yaz | Bayer | Drospirenone / Ethinyl Estradiol Tablets | Mylan | indicated for use by women to prevent pregnancy and for the treatment of acne vulgaris in women at least 14 years of age who have achieved menarche and desire an oral contraceptive for birth control | 4/24/2018 |
| Methylin | Mallinckrodt | Methylphenidate Chewable tablets | Camber Pharmaceuticals | is used to treat attention deficit hyperactivity disorder- ADHD | 4/30/2018 |
| Sabril | Lundbeck Pharms | Vigabatrin for Oral Solution | Amneal | indicated as adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss | 5/2/2018 |
| Sustiva | Bristol-Myers Squibb | Efavirenz Tablets | Camber Pharmaceuticals | used to treat HIV | 5/2/2018 |
| Opana | Endo Pharmaceuticals | Oxymorphone Tablets | Camber Pharmaceuticals | used to treat moderate to severe pain | 5/4/2018 |
| Zovirax | GlaxoSmithKline | Acyclovir Capsules | Heritage Pharmaceuticals | indicated for the treatment of herpes zoster, genital herpes and chickenpox | 5/14/2018 |
| Amidate | Hospira | Etomidate Injection | Heritage Pharmaceuticals | indicated for the induction of general anesthesia | 5/14/2018 |
| Mephyton | Valeant | Phytonadione Tablets | Amneal | is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces | 5/15/2018 |
| Welchol | Daiichi Sankyo | Colesevelam HCI | Amneal | is a lipid-lowering and glucose-lowering agent used to lower "bad" cholesterol in the blood | 5/17/2018 |
| Welchol | Daiichi Sankyo | Colesevelam HCl | Sun Pharmaceutical | is a lipid-lowering and glucose-lowering agent used to lower "bad" cholesterol in the blood | 5/17/2018 |
| Welchol | Daiichi Sankyo | Colesevelam HCl | Glenmark Generics | is a lipid-lowering and glucose-lowering agent used to lower "bad" cholesterol in the blood | 5/21/2018 |
| Methergine | Lupin | Methylergonovine Maleate Tablets | West-Ward Pharmaceuticals | indicated for the prevention and control of postpartum hemorrhage | 5/30/2018 |
| Provigil | Cephalon | Modafinil Tablets | Heritage Pharmaceuticals | indicated for the treatment of disorders such as narcolepsy, shift work sleep disorder and obstructive sleep apnea | 6/1/2018 |
| Methergine | Novartis | Methylergonovine Maleate Tabs | Lupin | indicated for the prevention and control of postpartum hemorrhage | 6/4/2018 |
| Viagra | Pfizer | Sildenafil Tablets | Camber Pharmaceuticals | treat erectile dysfunction (impotence) in men | 6/11/2018 |
| Tobi | Novartis | Tobramycin Inhalation Solution | Lupin | indicated for the management of cystic fibrosis patients with P. aeruginosa | 6/13/2018 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl Sublingual Film | Dr. Reddy's Laboratories | used to treat adults with opioid dependence/addiction | 6/15/2018 |
| Angiomax | The Medicines Company | Bivalirudin for Injection | Mylan | indicated for use as an anticoagulant in patients | 6/18/2018 |
| Viagra | Pfizer | Sildenafil Citrate Tablets | Aurobindo | treat erectile dysfunction (impotence) in men | 6/19/2018 |
| Sustiva | Bristol-Myers Squibb | Efavirenz Tablets | Cipla | is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg | 6/19/2018 |
| Levetiracetam in Sodium Chloride Injection | HQ Specialty Pharma | Levetiracetam in Sodium Chloride Injection | Dr. Reddy's Laboratories | is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy | 6/19/2018 |
| Depo-Testosterone | Pharmacia and Upjohn | Testosterone Cypionate for Injection | Cipla | is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone | 6/21/2018 |
| Reyataz | Bristol-Myers Squibb | Atazanavir Capsules | Aurobindo | indicated for use in combination with other antiretroviral agents for the treatment of HIV infection | 6/25/208 |
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