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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Gleevec Novartis Imatinib Mesylate Tablets Dr. Reddy's Labs used to treat certain types of cancer (such as Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors, and Myelodysplastic/ Myeloproliferative Diseases) 10/1/2018
Atacand HCT ANI Candesartan cilexetil / Hydrochlorathiazide Tablets ANI used to treat hypertension 10/4/2018
Potassium Chloride Oral Solution Genus Lifesciences Potassium Chloride Oral Solution  Lupin used for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods and/or diuretic dose reduction are insufficient 10/4/2018
Welchol Daiichi Sankyo Colesevelam HCl Tablets Dr. Reddy's Labs used as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin) 10/9/2018
Temovate Fougera Pharmaceuticals Clobetasol Propionate Ointment Lupin used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses 10/9/2018
Mepron GlaxoSmithKline Atovaquone Oral Solution Camber Pharmaceuticals used to treat or prevent pneumonia caused by a fungal infection called Pneumocystis carinii 10/12/2018
Androgel AbbVie Testosterone Topical Gel Perrigo used for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone 10/15/2018
Brethine ANI Terbutaline Sulfate Tablets ANI used for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema 10/16/2018
Depo-Provera Pfizer Medroxyprogesterone Acetate Injectable Suspension Mylan used to prevent pregnancy 10/18/2018
Isuprel  Hospira Isoproterenol HCl Single-Dose Vials Amneal used as adjunctive therapy to produce cardiac stimulation and vasodilation in the treatment of shock 10/19/2018
Onfi Lundbeck Clobazam Tablets Camber Pharmaceuticals used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 10/22/2018
Aloxi Helsinn Healthcare Simplist Palonosetron HCl Injection Prefilled Syringe Fresenius Kabi USA used in adults for: Moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses; highly emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses 10/22/2018
Onfi Lundbeck Clobazam Tablets Amneal used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 10/23/2018
Onfi Lundbeck Clobazam Tablets Upsher-Smith used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 10/23/2018
Onfi Lundbeck Clobazam Oral Suspension Upsher-Smith used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 10/23/2018
Onfi Lundbeck Clobazam Tablets Breckenridge used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 10/26/2018
Trisenox Teva Arsenic Trioxide Injection Fresenius Kabi USA used for relapsed or refractory acute promyelocytic leukemia 10/26/2018
Clobex Galderma  Clobetasol Propionate Lotion Akorn used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older 10/29/2018
Gleevec Novartis Imatinib Mesylate Hikma used to treat: Newly diagnosed adult and pediatric patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML) in chronic phase; patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML) in Blast Crisis (BC), Accelerated Phase (AP), or in the Chronic Phase (CP) after failure of Interferon-Alpha Therapy; patients with relapsed or refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL); Myelodysplastic/Myeloproliferative Diseases (MDS/MPD) associated with PDGFR (Platelet-Derived Growth Factor Receptor) gene re-arrangements with an FDA-approved test; Aggressive Systemic Mastocytosis (ASM) without the D816V c-Kit mutation; Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL) who have FIP1L1-PDGFRα Fusion Kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown; adult patients with unresectable, recurrent, and/or metastatic Dermatofibrosarcoma Protuberans (DFSP) 10/29/2018
Straterra  Eli Lilly Atomoxetine Capsules Dr. Reddy's Labs used to treat attention-deficit/hyperactivity disorder (ADHD) 10/31/2018
Levitra Bayer Vardenafil HCl Tablets Lannett used to treat erectile dysfunction 11/1/2018
Levitra Bayer Vardenafil HCl Tablets Zydus used to treat erectile dysfunction 11/1/2018
Biaxin XL AbbVie Clarithromycin ER Tablets Lannett used to treat a wide variety of bacterial respiratory tract infections 11/6/2018
Valcyte Roche Valganciclovir Tablets Cipla used to treat CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk 11/12/2018
Mepron GlaxoSmithKline Atovaquone Oral Suspension  Lupin used for the prevention of Pneumocystis Jirovecii Pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate Trimethoprimsulfamet-hoxazole (TMP-SMX); treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX 11/12/2018
Trisenox Teva Arsenic Trioxide Injection Nexus used for relapsed or refractory Acute Promyelocytic Leukemia 11/15/2018
Vidaza Celgene Azacitidine for Injection Armas Pharmaceuticals used for treating myelodysplastic syndrome, a form of cancer that leads to one or more blood cell types dropping to low numbers 11/19/2018
Halcion Pfizer Triazolam Tablets Hikma used for the short-term treatment of insomnia (generally seven to ten days) 11/19/2018
Finacea Leo Pharma Azelaic Acid Gel Teva used for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea 11/20/2018
Xenazine Valeant Tetrabenazine Tablets Lupin used to treat chorea associated with Huntington’s disease 11/21/2018
Zytiga Janssen Biotech Abiraterone Acetate Tablets Apotex used to treat metastatic prostate cancer 11/26/2018
EpiPen Mylan Epinephrine Auto-Injector Teva used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies 11/27/2018
Elidel Valeant Pimecrolimus Teva used as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable 11/27/2018
Hygroton Sanofi Aventis Chlorthalidone Tablets Dr. Reddy's Labs used to reduce extra salt and water in the body caused by conditions such as heart failure, liver disease, and kidney disease; decreasing extra salt and water in the body helps to decrease swelling (edema) and breathing problems caused by fluid in the lungs 11/28/2018
Solaraze Fougera Pharms Diclofenac Sodium Gel Perrigo used for the topical treatment of actinic keratoses 11/28/2018
Nystatin / Triamcinolone Acetonide Cream Taro Pharmaceuticals Nystatin / Triamcinolone Acetonide Cream  Lupin used to treat cutaneous candidiasis 11/30/2018
Rapaflo Allergan Silodosin Capsules Lupin used to treat the signs and symptoms of Benign Prostatic Hyperplasia (BPH) 12/4/2018
Prevacid SoluTab Takeda Lansoprazole Delayed-Release Orally Disintegrating Tablets Mylan used to treat high levels of stomach acid; active ulcers of the stomach and small intestine, Gastroesophageal Reflux Disease (GERD), and Zollinger-Ellison Syndrome 12/4/2018
Omegaven Fresenius Kabi USA Fish Oil Triglycerides Injectable Emulsion Fresenius Kabi USA used as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC) 12/10/2018
Onfi Lundbeck Clobazam Oral Suspension Hikma used for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 12/10/2018
Onfi Lundbeck Clobazam Tablets Hikma used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 12/10/2018
Topicort Taro Desoximetasone Topical Spray Perrigo used to treat plaque psoriasis in patients 18 years of age or older 12/10/2018
Prilosec AstraZeneca Omeprazole DR Tablets (OTC) Dr. Reddy's Labs used to treat frequent heartburn occurring two or more days per week in adults 12/11/2018
Albenza Impax Albendazole Tablets Strides used to treat certain infections caused by tapeworm 12/11/2018
Xylocaine  AstraZeneca Lidocaine Ointment Strides used topically to numb
and relieve pain from minor burns, skin abrasions, and other painful conditions affecting mucous membranes; also used to numb the skin before certain medical procedures
12/12/2018
Canasa Allergan Mesalamine Rectal Suppository Mylan used to treat mildly to moderately active ulcerative proctitis 12/17/2018
Lialda Shire Mesalamine Delayed-Release Tablets Mylan used for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC 12/17/2018
Ampyra Acorda Therapeutics Dalfampridine Extended-Release Tablets Hikma used to help improve walking in adult patients with multiple sclerosis as demonstrated by an increase in walking speed 12/19/2018
Aggrenox Boehringer Ingelheim Aspirin / Extended-Release Dipyridamole Capsules Dr. Reddy's Labs used to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis 12/24/2018
Renvela Sanofi Sevelamer Carbonate for Oral Suspension Dr. Reddy's Labs used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis 12/27/2018

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