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Generic Launches

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

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