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New Drug Approvals Archive - October 2012

See also: New Indications and Dosage Forms for October 2012

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.

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.

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.

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.

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