New Drug Approvals Archive - October 2012

Cystaran (cysteamine hydrochloride) Ophthalmic Solution

Date of Approval: October 2, 2012
Company: Sigma-Tau Pharmaceuticals, Inc.
Treatment for: Cystinosis

Cystaran (cysteamine cysteamine ophthalmic solution) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

• Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution) 0.44%
• Cystaran (cysteamine hydrochloride) FDA Approval History

Abraxane (paclitaxel protein-bound)

New Indication Approved: October 11, 2012

• FDA Approves Abraxane for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
• Abraxane (paclitaxel protein-bound) FDA Approval History

Jetrea (ocriplasmin) Intravitreal Injection

Date of Approval: October 17, 2012
Company: ThromboGenics NV
Treatment for: Vitreomacular Adhesion

Jetrea (ocriplasmin) is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion.

• FDA Approves Jetrea for Symptomatic Vitreomacular Adhesion in the Eyes
• Jetrea (ocriplasmin) FDA Approval History

Fycompa (perampanel) Tablets and Oral Suspension

Date of Approval: October 22, 2012
Company: Eisai Inc.
Treatment for: Epilepsy, Seizures

Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated for the treatment of partial-onset seizures, and as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy.

• FDA Approves Fycompa to Treat Seizures
• Fycompa (perampanel) FDA Approval History

Synribo (omacetaxine mepesuccinate)

Date of Approval: October 26, 2012
Company: Teva Pharmaceuticals
Treatment for: Chronic Myelogenous Leukemia

Synribo (omacetaxine mepesuccinate) is a first-in-class small molecule drug for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia.

• FDA Approves Synribo for Chronic Myelogenous Leukemia
• Synribo (omacetaxine mepesuccinate) FDA Approval History

Minivelle (estradiol)

New Indication Approved: September 23, 2014

• Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle
• Minivelle (estradiol) FDA Approval History

Fycompa (perampanel)

New Indication Approved: June 19, 2015

• FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures
• Fycompa (perampanel) FDA Approval History

Fycompa (perampanel)

New Dosage Form Approved: May 2, 2016

• Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension
• Fycompa (perampanel) FDA Approval History

Fycompa (perampanel)

New Indication Approved: July 26, 2017

• FDA Approves Additional Use of Antiepileptic Drug Fycompa as Monotherapy for Partial-onset Seizures
• Fycompa (perampanel) FDA Approval History