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New Drug Approvals Archive - October 2012

October 2012

October 2

Cystaran (cysteamine hydrochloride) Ophthalmic Solution - formerly Cystoran

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.

Cystaran (cysteamine hydrochloride) FDA Approval History

October 12

Abraxane (paclitaxel protein-bound)

New Indication Approved: October 11, 2012

Abraxane (paclitaxel protein-bound) FDA Approval History

October 17

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.

Jetrea (ocriplasmin) FDA Approval History

October 22

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.

Fycompa (perampanel) FDA Approval History

October 26

Synribo (omacetaxine mepesuccinate) - formerly Omapro

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.

Synribo (omacetaxine mepesuccinate) FDA Approval History

September 24

Minivelle (estradiol)

New Indication Approved: September 23, 2014

Minivelle (estradiol) FDA Approval History

June 22

Fycompa (perampanel)

New Indication Approved: June 19, 2015

Fycompa (perampanel) FDA Approval History

May 2

Fycompa (perampanel)

New Dosage Form Approved: May 2, 2016

Fycompa (perampanel) FDA Approval History

July 27

Fycompa (perampanel)

New Indication Approved: July 26, 2017

Fycompa (perampanel) FDA Approval History

New Drug Approvals Archive