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