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New Drug Approvals Archive - May 2019

See also: New Indications and Dosage Forms for May 2019

May 2019

Dengvaxia (dengue tetravalent vaccine, live) Injection

Date of Approval: May 1, 2019
Company: Sanofi Pasteur, Inc.
Treatment for: Prevention of Dengue Disease

Dengvaxia (dengue tetravalent vaccine, live) is a vaccine indicated for the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people 9 years through 16 years of age living in endemic areas who have laboratory-confirmed previous dengue infection.

Qternmet XR (dapagliflozin, metformin hydrochloride and saxagliptin) Extended-Release Tablets

Date of Approval: May 2, 2019
Company: AstraZeneca
Treatment for: Diabetes Type 2

Qternmet XR (dapagliflozin, metformin hydrochloride and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, biguanide and dipeptidyl peptidase-4 (DPP-4) inhibitor combination indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Vyndaqel (tafamidis meglumine) Capsules

Date of Approval: May 3, 2019
Company: Pfizer Inc.
Treatment for: Cardiomyopathy of Transthyretin-Mediated Amyloidosis

Vyndaqel (tafamidis meglumine) is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis.

Ruzurgi (amifampridine) Tablets

Date of Approval: May 6, 2019
Company: Jacobus Pharmaceutical Company, Inc.
Treatment for: Lambert-Eaton Myasthenic Syndrome

Ruzurgi (amifampridine) is a potassium-channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years to less than 17 years of age.

Nayzilam (midazolam) Nasal Spray

Date of Approval: May 17, 2019
Company: UCB
Treatment for: Seizure Clusters

Nayzilam (midazolam) is a nasally administered benzodiazepine indicated for the acute treatment of seizure clusters.

Piqray (alpelisib) Tablets

Date of Approval: May 24, 2019
Company: Novartis
Treatment for: Breast Cancer

Piqray (alpelisib) is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR positive, HER2-negative, PIK3CA-mutated breast cancer.

Zolgensma (onasemnogene abeparvovec-xioi) Suspension for Intravenous Infusion

Date of Approval: May 24, 2019
Company: Novartis
Treatment for: Spinal Muscular Atrophy

Zolgensma (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA).

Slynd (drospirenone) Tablets

Date of Approval: May 23, 2019
Company: Exeltis
Treatment for: Contraception

Slynd (drospirenone) is a progestin oral contraceptive for birth control.

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