Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Aggrenox | Boehringer Ingelheim | Aspirin / Extended-Release Dipyridamole Capsules | Teva | reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis | 7/1/2015 |
| Axert | Janssen | Almotriptan Malate Tablets | Teva | acute treatment of migraine attacks in adults with a history of migraine with or without aura; acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more | 7/8/2015 |
| Targretin | Valeant | Bexarotene | Mylan | treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy | 7/9/2015 |
| Namenda | Forest Labs | Memantine Hydrochloride Tablets | Amneal Pharms | treatment of moderate to severe dementia of the Alzheimer's type | 7/11/2015 |
| Namenda | Merz Pharma | Memantine Hydrochloride Tablets | Dr. Reddy's Labs | treatment of moderate to severe dementia of the Alzheimer's type | 7/12/2015 |
| Tobi | Novartis | Tobramycin Inhalation Solution | Amneal Pharms | for the management of cystic fibrosis patients with Pseudomonas aeruginosa | 7/13/2015 |
| Namenda | Forest Labs | Memantine Hydrochloride Tablets | Mylan | treatment of moderate to severe dementia of the Alzheimer's type | 7/14/2015 |
| Angiomax | The Medicines Company | Bivalirudin for Injection | Hospira | indicated as an anticoagulant | 7/16/2015 |
| Pulmicort | AstraZeneca | Budesonide Inhalation Suspension | Sandoz | indicated for maintenance treatment of asthma and as a prophylactic therapy in children 12 months to 8 years of age | 7/28/2015 |
| Megace ES | E. R. Squibb & Sons | Megestrol Acetate, USP, Oral Suspension | Par Pharm | indicated for the treatment of anorexia, cachexia, or an unexplained significant weigh loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) | 7/29/2015 |
| Sodium Edecrin | Alton Pharma | Ethrynate Sodium for Injection USP | Par Pharm | treatment of edema | 8/4/2015 |
| Nexium | AstraZeneca | Esomeprazole Magnesium Delayed-Release Capsules | Mylan | treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older | 8/5/2015 |
| Lidoderm | Endo Pharm | Lidocaine Patch 5% | Mylan | indicated for relief of pain associated with post-herpetic neuralgia | 8/10/2015 |
| Mirapex ER | Boehringer Ingelheim | Pramipexole Dihydrochloride ER Tablets | Dr. Reddy's Labs | treatment for Parkinson's disease | 8/11/2015 |
| Xenazine | Valeant | Tetrabenazine | Sun Pharm |
treatment
of chorea associated with Huntington’s disease.
|
8/17/2015 |
| Abilify | Bristol-Myers Squibb | Aripiprazole Oral Solution | Amneal Pharms | add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy. Treatment of manic or mixed episodes associated with Bipolar I Disorder I adults and in pediatric patients 10 to 17 years of age. Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age. Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age. Treatment of Tourette's Disorder in pediatric patients 6 to 18 years of age. | 8/18/2015 |
| Abilify | Bristol-Myers Squibb | Aripiprazole Oral Solution | Silarx Pharms | add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy. Treatment of manic or mixed episodes associated with Bipolar I Disorder I adults and in pediatric patients 10 to 17 years of age. Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age. Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age. Treatment of Tourette's Disorder in pediatric patients 6 to 18 years of age. | 8/18/2015 |
| Yaz | Bayer HealthCare | Drospirenone / Ethinyl Estradiol Tablets | Glenmark Pharms | prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception | 8/19/2015 |
| Zosyn | Pfizer | Piperacillin / Tazobactam for Injection | Mylan | indicated for treatment of patients with moderate to severe infections caused by susceptible isolates of certain bacteria | 8/25/2015 |
| Dibenzyline | WellSpring Pharms | Phenoxybenzamine Hydrochloride Capsules | Roxane Labs | treating high blood pressure and sweating caused by a certain kind of tumor (pheochromocytoma) | 8/25/2015 |
| Exelon | Novartis | Rivastigmine Transdermal System | Alvogen | treatment of mild, moderate, and severe dementia of the Alzheimer’s type, and mild to moderate dementia associated with Parkinson’s disease. | 8/31/2015 |
| Exelon | Novartis | Rivastigmine Transdermal System | Sandoz | treatment of mild, moderate, and severe dementia of the Alzheimer’s type, and mild to moderate dementia associated with Parkinson’s disease. | 8/31/2015 |
| Cymbalta DR | Eli Lilly and Co. | Duloxetine DR Capsules | Lupin | Major Depressive Disorder; Generalized Anxiety Disorder; Diabetic Peripheral Neuropathic Pain; Chronic Musculoskeletal Pain | 9/3/2015 |
| Vfend | PF Prism | Voriconazole Tablets | Glenmark Pharms | treating certain fungal infections | 9/4/2015 |
| Yasmin | Bayer | Drospirenone / Ethinyl Estradiol Tablets | Mylan | indicated for use by women to prevent pregnancy | 9/8/2015 |
| Unasyn | Pfizer | Ampicillin / Sulbactam for Injection | Mylan | indicated for the treatment of infections due to susceptible strains of designated microorganisms in skin and skin structure infections, intra-abdominal infections and gynecological infections | 9/14/2015 |
| Lescol XL | Novartis | Fluvastatin Sodium ER Tablets | Mylan | indicated to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride and increase HDL-C in adults with primary hypercholesterolemia and mixed dyslipidemia | 9/18/2015 |
| BenzaClin | Valeant | Phosphate 1% / Benzoyl Peroxide 5% | Perrigo | indicated for the topical treatment of acne vulgaris | 9/22/2015 |
| Invega | Janssen | Paliperidone ER Tablets | Allergan | treatment of schizophrenia in adults and adolescents (12-17 years of age) | 9/25/2015 |
| Invega | Janssen | Paliperidone ER Tablets | Patriot Pharm | treatment of schizophrenia in adults and adolescents (12-17 years of age) | 9/25/2015 |
| Nexium | AstraZeneca | Esomeprazole Magnesium DR Capsules | Dr. Reddy's Labs | treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older | 9/28/2015 |
| Invega | Janssen | Paliperidone ER Tablets | Mylan | treatment of schizophrenia in adults and adolescents (12-17 years of age) in addition to schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants in adults | 9/28/2015 |
| Orap | Teva | Pimozide | Par Pharm | antipsychotic indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment | 9/30/2015 |
