New Drug Approvals Archive - October 2012
Cystaran (cysteamine hydrochloride) Ophthalmic Solution - formerly Cystoran
Date of Approval: October 2, 2012
Cystaran (cysteamine cysteamine ophthalmic solution) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
Abraxane (paclitaxel protein-bound)
New Indication Approved: October 11, 2012
Jetrea (ocriplasmin) Intravitreal Injection
Date of Approval: October 17, 2012
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
Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated as adjunctive therapy for the treatment of partial-onset seizures and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy.
Synribo (omacetaxine mepesuccinate) - formerly Omapro
Date of Approval: October 26, 2012
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.
New Indication Approved: September 23, 2014
New Indication Approved: June 19, 2015
New Dosage Form Approved: May 2, 2016