Expanded Indications/Labeling Changes for February 2009

[chantell.reagan]

Expanded indications:

Copaxone (glatiramer acetate) injection by Teva
Expanded indication: for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
• Link to FDA letter

Symbicort (budesonide/formoterol) inhalation aerosol by AstraZeneca
Expanded indication: treatment of Chronic Obstructive Pulmonary Disease (COPD)
• Link to FDA letter

New dosage forms:

Temodar (temozolomide) for injection 100 mg/vial by Schering
New dosage form indication: for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and also for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine
-already available in oral formulation
• Link to FDA letter

Apidra Solostar (insulin glulisine [rDNA origin] injection) by sanofi-aventis
New dosage form indication: new injection pen indicated to improve glycemic control in adults and children (4 years and older) with type 1 diabetes or adults with type 2 diabetes
-expected to be in pharmacies this year
• Link to sanofi-aventis press release 2/09

Safety concerns:

Metoclopramide-containing drugs
Black-box warning: Manufacturers of metoclopramide must add a boxed warning about the risk of its long-term or high-dose use, which has been linked to tardive dyskinesia; manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS
• Link to FDA news release 2/09

Raptiva (efalizumab)
Public health advisory: FDA is continuing to investigate the risk of progressive multifocal leukoencephalopathy (PML), which has been confirmed in 3 patients and possibly suspected in 1 patient.
• Link to FDA updated safety information for Raptiva 2/09

Zonegran (zonisamide)
FDA health care professional notification: can cause metabolic acidosis in some patients; patients with predisposing conditions or therapies may be at greater risk, appearing to be more frequent and severe in younger patients
• Link to FDA health care professional notification 2/09

Sources:
U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER