|
Reference Listed Drug |
NDA Holder |
Generic Drug Name |
ANDA Applicant(s) |
Indication |
Launch Date |
|
Maxalt MLT |
Merck |
Rizatriptan Benzoate Orally Disintegrating Tablets |
Glenmark Generics |
treatment of migraine headaches; Maxalt will only treat a headache that has already begun |
7/2/2013 |
|
Metrogel 1% |
Galderma Laboratories |
Metronidazole 1% topical gel |
Sandoz |
topical treatment of inflammatory lesions of rosacea |
7/2/2013 |
|
Evoxac |
Daiichi Sankyo |
Cevimeline Hydrochloride Capsules |
Roxane Laboratories |
treatment of dry mouth in people with Sjögren's Syndrome |
7/8/2013 |
|
Dacogen |
Eisai Inc. under license from Astex Pharmaceuticals |
Decitabine for Injection |
Dr. Reddy's Laboratories |
treatment of myelodysplastic syndromes (certain types of blood or bone marrow cancer) |
7/11/2013 |
|
Prandin |
Novo Nordisk |
Repaglinide Tablets |
Sun Pharmaceutical Industries |
adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus |
7/12/2013 |
|
Lamictal ODT |
GlaxoSmithKline |
Lamotrigine Orally Disintegrating Tablets |
Actavis |
treatment of epilepsy and bipolar disorder |
7/15/2013 |
|
Trilipix |
Abbott |
Fenofibric Acid Delayed-release Capsules |
Mylan Pharmaceuticals |
an adjunct to diet in combination with a statin to reduce triglyceride and increase high-density lipoprotein cholesterol in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their low-density lipoprotein cholesterol goal |
7/15/2013 |
|
Nor-Q.D. Tablets |
Watson Laboratories (now Actavis, Inc.) |
Norethindrone Tablets USP (0.35 mg) |
Mylan Pharmaceuticals |
prevention of pregnancy |
7/16/2013 |
|
Trilipix |
AbbVie |
Fenofibric Acid Delayed-release Capsules |
Par Pharmaceutical |
in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal |
7/18/2013 |
|
Aricept |
Eisai Inc. under license from Eisai R&D Management |
Donepezil Hydrochloride Tablets |
Dr. Reddy's Laboratories |
treatment of mild to moderate dementia caused by Alzheimer's disease |
7/27/2013 |
|
Cutivate |
Fougera Pharmaceuticals |
Fluticasone Propionate Lotion, 0.05% |
Perrigo |
relief of inflammatory and pruritic manifestations of atopic dermatitis in patients 1 year of age or older |
7/31/2013 |
|
Micro-K 10 ExtenCaps |
Nesher Pharmaceuticals |
Potassium Chloride Extended-release Capsules |
Amneal Pharmaceuticals |
prevention of hypokalemia |
8/2/2013 |
|
Revatio |
Pfizer |
Sildenafil Tablets, USP |
Amneal Pharmaceuticals |
pulmonary arterial hypertension and improve exercise capacity in men and women. |
8/2/2013 |
|
Viramune |
Boehringer Ingelheim Pharmaceuticals |
Nevirapine Tablets, USP |
Amneal Pharmaceuticals |
treatment of HIV |
8/2/2013 |
|
Skelaxin |
King Pharmaceuticals Research and Development |
Metaxalone Tablets |
Amneal Pharmaceuticals |
muscle relaxant blocking nerve impulses in the brain |
8/2/2013 |
|
Coumadin |
Bristol-Myers Squibb |
Warfarin Sodium Tablets |
Amneal Pharmaceuticals |
treatment of venous thrombosis and its extension, pulmonary embolism (PE); thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement; and reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction |
8/2/2013 |
|
Derma-Smoothe |
Hill Dermac |
Fluocinolone Acetonide Scalp Oil, 0.01% |
Perrigo |
topical treatment of atopic dermatitis in adult patients and the topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks |
8/12/2013 |
|
Temodar |
Merck Sharp and Dohme |
temozolomide |
Teva Pharmaceuticals / Perrigo Company |
treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine |
8/12/2013 |
|
Temodar |
Merck Sharp and Dohme |
temozolomide capsules |
Sandoz |
treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine |
8/13/2013 |
|
Depakote ER |
Sanofi |
Divalproex Sodium Extended-release Tablets |
Dr. Reddy's Laboratories |
treatment of various types of seizure disorders; Divalproex sodium is sometimes used together with other seizure medications |
8/19/2013 |
|
Opana ER |
Endo-Health Solutions |
Oxymorphone Hydrochloride Extended-release Tablets |
Actavis |
relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time |
9/12/2013 |
|
Prevacid |
Takeda Pharmaceuticals U.S.A. |
Lansoprazole Delayed-release Capsules |
Sun Pharmaceutical |
short-term treatment (for 4 week) for healing and symptom relief of active duodenal ulcer |
9/14/2013 |
|
Niaspan |
AbbVie |
Niacin Extended-release Tablets |
Teva Pharmaceutical Industries |
reduce elevated TC, LDL-C, Apo B and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia |
9/20/2013 |
|
Nitrolingual Pumpspray |
Pohl Boskamp |
Nitroglycerin Spray, 400 mcg/spray |
Perrigo |
acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease |
9/23/2013 |
|
Vidaza |
Celgene |
Azacitidine for Injection |
Sandoz |
treatment of myelodysplastic syndrome (MDS) |
9/23/2013 |
|
Adenoscan |
Astellas Pharmaceuticals |
Adenosine Injection |
Teva Pharmaceutical Industries |
adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately |
9/24/2013 |
|
Glucotrol XL |
Pfizer |
Glipizide Extended-release Tablets |
Par Pharmaceutical |
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
9/25/2013 |
|
Vfend |
Pfizer |
Voriconazole for Oral Suspension |
Mylan Pharmaceuticals |
triazole antifungal drug |
9/30/2013 |
