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May 2019 New Drugs May 2019 Learn more New drugs Drug name Therapeutic category Indication(s) Launch information Manufacturer(s) ® Dengvaxia For the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. Dengvaxia is approved for use in (dengue tetravalent vaccine, Vaccine individuals 9 through 16 years of age with laboratory- TBD live)* confirmed previous dengue infection and living in endemic Sanofi Pasteur areas. Ingrezza® (valbenazine) Vesicular monoamine initiation pack Treatment of adults with tardive dyskinesia April 22, 2019 transporter-2 inhibitor Neurocrine Biosciences ® Nayzilam (midazolam)† Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive single-dose nasal spray Benzodiazepine TBD seizures) that are distinct from a patient’s usual seizure UCB pattern in patients with epilepsy 12 years of age and older In combination with Faslodex® (fulvestrant) for the treatment ® of postmenopausal women, and men, with hormone receptor- Piqray (alpelisib)* Phosphoinositide 3-kinase CA positive, human epidermal growth factor receptor 2-negative, May 30, 2019 Novartis inhibitor PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen 1 RxHighlights May 2019 Drug name Therapeutic category Indication(s) Launch information Manufacturer(s) ® Qternmet XR Sodium-glucose cotransporter 2 (dapagliflozin/saxagliptin/ Adjunct to diet and exercise to improve glycemic control in inhibitor/dipeptidyl peptidase-4 TBD adults with type 2 diabetes mellitus metformin) inhibitor/biguanide AstraZeneca ™ (amifampridine)*† Treatment of Lambert-Eaton myasthenic syndrome in patients Ruzurgi Potassium channel blocker June 6, 2019 6 to less than 17 years of age Jacobus Pharmaceuticals ® Slynd (drospirenone) For use by females of reproductive potential to prevent Progesterone TBD Exeltis pregnancy ® Vyndaqel Treatment of the cardiomyopathy of wild type or hereditary (tafamidis meglumine)*, ∆ Transthyretin stabilizer transthyretin-mediated amyloidosis in adults to reduce May 13, 2019 ™ Vyndamax (tafamidis)* cardiovascular (CV) mortality and CV-related hospitalization Pfizer ® Zolgensma Treatment of pediatric patients less than 2 years of age with (onasemnogene abeparvovec- *† Gene therapy spinal muscular atrophy with bi-allelic mutations in the May 29, 2019 xioi) survival motor neuron 1 gene Novartis/AveXis *New molecular entity †Orphan Drug §Biosimilar ∆Vyndaqel; Vyndamax 2H2019 TBD: To be determined 2 RxHighlights May 2019 Learn more New generics Drug name Generic Strength(s) & dosage Therapeutic use Launch information Manufacturer(s) manufacturer(s) form(s) ® Cuprimine (penicillamine) Amerigen†, Wilson's disease, cystinuria, and ¥ * 250 mg capsules May 8, 2019 Oceanside rheumatoid arthritis Bausch Health ® Delzicol (mesalamine) † * 400 mg delayed # Teva , Greenstone Ulcerative colitis May 10, 2019 release capsules Allergan ® Faslodex (fulvestrant) Sandoz†, Amneal† 250 mg/mL injection Breast cancer May 31, 2019^ AstraZeneca ® Lotemax (loteprednol etabonate) † 0.5% ophthalmic Post-operative inflammation and pain Akorn May 6, 2019 suspension following ocular surgery Bausch Health ® † Urinary tract infections, otitis media, Suprax (cefixime) Ascend Laboratories , 400 mg capsules pharyngitis/tonsillitis, acute exacerbations May 16, 2019 Lupin* Lupin of chronic bronchitis, and gonorrhea Amneal†, Par/Endo†, ® Alvogen†, Tracleer (bosentan) † † 62.5 mg and 125 mg ∆ Lupin/Natco , Sun , Pulmonary arterial hypertension May 5, 2019 † tablets Actelion Teva/Watson , West- Ward/Hikma†, Zydus† ® Tarceva (erlotinib) † † 25 mg, 100 mg, and Non-small cell lung cancer and pancreatic § Teva , Mylan May 9, 2019 Genentech 150 mg tablets cancer ® aspirin/omeprazole: Yosprala (aspirin/omeprazole) Secondary prevention of cardiovascular Basiem* 81/40 mg, 325/40 mg April 19, 2019 and cerebrovascular events Aralez tablets †A-rated generic manufacturer *Authorized generic ¥ Oceanside launch May 10,2019 #Greenstone launch May 13, 2019 ∆Amneal, Par/Endo, Alvogen, Lupin/Natco, Sun, West-Ward/Hikma; Teva/Watson and Zydus TBD §Mylan launched 25 mg, 100 mg and 150 mg tablets; Teva launched 100 mg and 150 mg tablets ^Amneal TBD 3 RxHighlights May 2019 Learn more Indications/label updates Drug name Type Description Manufacturer(s) ® Bavencio (avelumab) New indication In combination with Inlyta® (axitinib) for the first-line treatment of advanced renal cell carcinoma EMD Serono, Pfizer Treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥ 400 ng/mL ® ® Cyramza (ramucirumab) New indication, and have been treated with Nexavar (sorafenib) removal of boxed Eli Lilly warning The Boxed Warning for hemorrhage, gastrointestinal perforation, and impaired wound healing was removed from the Cyramza drug label. ® Eylea (aflibercept) Expanded indication Treatment of diabetic retinopathy Regeneron ® Fragmin (dalteparin) Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in New indication Pfizer patients ≥ 1 month of age ® Gattex (teduglutide) Treatment of patients ≥ 1 year of age with short bowel syndrome who are dependent on Expanded indication Takeda Pharmaceuticals parenteral support ® Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction Herzuma (trastuzumab-pkrb) New and expanded adenocarcinoma who have not received prior treatment for metastatic disease, and for adjuvant Teva, Celltrion indications treatment of HER2 overexpressing node positive or node negative breast cancer as a single agent following multi-modality anthracycline based therapy ® Jakafi (ruxolitinib) New orphan indication Treatment of steroid-refractory acute graft-versus-host disease in patients ≥ 12 years of age Incyte ® Kadcyla As a single agent, for the adjuvant treatment of patients with HER2-positive early breast cancer ® (ado-trastuzumab emtansine) New indication who have residual invasive disease after neoadjuvant taxane and Herceptin (trastuzumab)- based treatment Genentech 4 RxHighlights May 2019 ® Livalo (pitavastatin) An adjunctive therapy to diet in patients ≥ 8 years of age with heterozygous familial Expanded indication hypercholesterolemia to reduce elevated total cholesterol, low-density lipoprotein cholesterol, Kowa Pharmaceuticals and apolipoprotein B ® Lyrica (pregabalin) capsules and oral solution Expanded indication Adjunctive therapy for the treatment of partial-onset seizures in patients ≥ 1 month of age Pfizer ® Qtern (dapagliflozin/saxagliptin) Expanded indication Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus AstraZeneca ® Revlimid (lenalidomide) In combination with a rituximab product for the treatment of adult patients with previously treated New indications follicular lymphoma and marginal zone lymphoma Celgene ® Sorilux (calcipotriene) foam Expanded indication Topical treatment of plaque psoriasis of the scalp and body in patients ≥ 12 years of age Mayne Pharma ® Tibsovo (ivosidenib) Treatment of newly-diagnosed acute myeloid leukemia with a susceptible isocitrate Expanded indication dehydrogenase-1 mutation in adults ≥ 75 years old or who have comorbidities that preclude use Agios of intensive induction chemotherapy Treatment of adult patients with previously untreated diffuse large B-cell, CD20-positive non- ® Hodgkin’s lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, and Truxima (rituximab-abbs) New and expanded prednisone or other anthracycline-based chemotherapy regimens; and with previously untreated indications Teva, Celltrion and previously treated CD20-positive chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide ® Venclexta (venetoclax) Expanded indication Treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma Roche ® Vraylar (cariprazine) New indication Treatment of depressive episodes associated with bipolar I disorder Allergan, Gedeon Richter ® Xeomin (incobotulinumtoxinA) Expanded indication Treatment of blepharospasm Merz Pharmaceuticals 5 RxHighlights May 2019 Learn more Drug safety news Drug name Description Manufacturer(s) Xospata® (gilteritinib) A new Boxed Warning was added to the Xospata drug label regarding differentiation syndrome Astellas Pharma Learn more Drug recalls/withdrawals/shortages/discontinuations Drug name Dosage form(s) Type Description Manufacturer(s) Heritage Pharmaceuticals recalled two lots of amikacin injection and prochlorperazine injection due to microbial growth having been Amikacin sulfate detected in a couple unreleased sublots, which may indicate a lack of injection, 1 g/4 mL sterility in the other sublots. Amikacin and prochlorperazine Prochlorperazine Recall Amikacin injection is indicated in the short-term treatment of serious Heritage Pharmaceuticals edisylate injection, 10 infections due to susceptible strains of certain types of Gram-negative mg/2 mL bacteria. Prochlorperazine injection is indicated to control severe nausea and vomiting and for the treatment of schizophrenia. Sagent recalled one lot of ketorolac injection due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the Ketorolac tromethamine products. 60 mg/ 2 mL injection Recall Sagent Pharmaceuticals Ketorolac tromethamine injection is indicated for the short-term management of moderately severe
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