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New Drug Approvals Archive - 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.

Read more: Spritam (levetiracetam) FDA Approval History

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.

Read more: Keveyis (dichlorphenamide) FDA Approval History

OxyContin (oxycodone)

Patient Population Altered: August 13, 2015

Procysbi (cysteamine bitartrate)

Patient Population Altered: August 14, 2015
Treatment for: Nephropathic Cystinosis

Read more: Procysbi (cysteamine bitartrate) FDA Approval History

Addyi (flibanserin) Tablets

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

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

Read more: Addyi (flibanserin) FDA Approval History

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.

Read more: Synjardy (empagliflozin and metformin) FDA Approval History

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.

Read more: Repatha (evolocumab) FDA Approval History

Repatha (evolocumab)

New Formulation Approved: July 8, 2016
Treatment for: High Cholesterol; Prevention of Heart Attack and Stroke

Read more: Repatha (evolocumab) FDA Approval History

Repatha (evolocumab)

New Indication Approved: December 1, 2017
Treatment for: High Cholesterol; Prevention of Heart Attack and Stroke

Read more: Repatha (evolocumab) FDA Approval History

New Drug Approvals Archive