New Drug Approvals Archive - 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.

• FDA Approves Spritam (levetiracetam) as the First 3D Printed Drug Product

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.

• FDA Approves Keveyis (dichlorphenamide) for Primary Hyperkalemic and Hypokalemic Periodic Paralysis

Keveyis (dichlorphenamide) FDA Approval History

Zubsolv (buprenorphine and naloxone)

New Indication Approved: August 10, 2015

• FDA Approves Zubsolv for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence

Zubsolv (buprenorphine and naloxone) FDA Approval History

Onsolis (fentanyl)

New Formulation Approved: August 11, 2015

• BioDelivery Sciences Announces FDA Approval of New Formulation of Onsolis (fentanyl buccal soluble film) CII

Onsolis (fentanyl) FDA Approval History

OxyContin (oxycodone)

Patient Population Altered: August 13, 2015

• FDA Approves Oxycontin (oxycodone) for Children as Young as 11

Procysbi (cysteamine bitartrate)

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

• FDA Approves Expanded Label for Procysbi to Treat Children Aged 2-6 Years With Nephropathic Cystinosis

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.

• FDA Approves Addyi (flibanserin) for Hypoactive Sexual Desire Disorder in Premenopausal Women

Addyi (flibanserin) FDA Approval History

Promacta (eltrombopag)

Patient Population Altered: August 24, 2015

• FDA Extends Use of Promacta (eltrombopag) in Pediatric Patients with Immune Thrombocytopenic Purpura

Promacta (eltrombopag) 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.

• FDA Approves Synjardy (empagliflozin/metformin hydrochloride) for Type 2 Diabetes

Synjardy (empagliflozin and metformin) FDA Approval History

Repatha (evolocumab) Injection

Date of Approval: August 27, 2015
Company: Amgen Inc.
Treatment for: High Cholesterol

Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) indicated for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

• FDA Approves Repatha (evolocumab) to Treat Certain Patients with High Cholesterol

Repatha (evolocumab) FDA Approval History

Aptiom (eslicarbazepine acetate)

New Indication Approved: August 27, 2015

• FDA Approves New Indication for Aptiom (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures

Aptiom (eslicarbazepine acetate) FDA Approval History

Repatha (evolocumab)

New Formulation Approved: July 8, 2016
Treatment for: High Cholesterol

• FDA Approves Repatha (evolocumab) Pushtronex - First And Only Single Monthly Injection for a PCSK9 Inhibitor

Repatha (evolocumab) FDA Approval History

Synjardy (empagliflozin and metformin)

Patient Population Altered: July 8, 2016

• FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults

Synjardy (empagliflozin and metformin) FDA Approval History

Synjardy (empagliflozin and metformin)

New Formulation Approved: December 12, 2016

• FDA Approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) for Adults with Type 2 Diabetes

Synjardy (empagliflozin and metformin) FDA Approval History