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 |