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New Drug Approvals Archive

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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

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

Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.

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