Generic Launches

Winter 2019

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