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New Drug Approvals Archive - August 2015

See also: New Indications and Dosage Forms for August 2015

August 2015

Spritam (levetiracetam) Tablets

Date of Approval: August 3, 2015
Company: Aprecia Pharmaceuticals Company
Treatment for: Seizures, Epilepsy

Spritam (levetiracetam) is a 3D printed drug product used as adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.

Keveyis (dichlorphenamide) Tablets

Date of Approval: August 7, 2015
Company: Taro Pharmaceutical Industries Ltd.
Treatment for: Primary Hyperkalemic and Hypokalemic Periodic Paralysis

Keveyis (dichlorphenamide) is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic and hypokalemic periodic paralysis.

Addyi (flibanserin) Tablets

Date of Approval: August 18, 2015
Company: Sprout Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder

Addyi (flibanserin) is a non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women.

Synjardy (empagliflozin and metformin) Tablets

Date of Approval: August 26, 2015
Company: Eli Lilly and Company and Boehringer Ingelheim
Treatment for: Diabetes Type 2

Synjardy (empagliflozin and metformin hydrochloride) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination for the treatment of adults with type 2 diabetes.

Repatha (evolocumab) Injection

Date of Approval: August 27, 2015
Company: Amgen Inc.
Treatment for: High Cholesterol; Prevention of Heart Attack and Stroke

Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) indicated for the treatment of patients with heterozygous familial hypercholesterolemia; homozygous familial hypercholesterolemia; and to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.

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