FDA actions in brief, October 2009 (Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, Bepreve)

Recent FDA approvals (through October 2009) related to Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, and Bepreve

Vigabatrin oral solution and tablets (Sabril, Lundbeck) were approved as monotherapy for patients aged 1 month to 2 years with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss and as adjunctive therapy for adult patients with refractory complex partial seizures who have inadequate response to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss.

Antihemophilic factor (recombinant) (Helixate FS, CSL Behring) was approved for routine prophylaxis in children aged ≤16 years with hemophilia A and without pre-existing joint damage.

Valganciclovir (Valcyte, Roche) was approved for the prevention of cytomegalovirus (CMV) disease in patients aged 4 months to 16 years who are undergoing kidney or heart transplant and are at high risk of developing CMV disease. FDA also approved a pediatric oral solution of valganciclovir for this patient population.

Levocetirizine (Xyzal, UCB/Sanofi-Aventis) was approved for the relief of symptoms of perennial allergic rhinitis and chronic idiopathic urticaria in patients aged ≥6 months and for the symptoms of seasonal allergic rhinitis in patients aged ≥2 years.

Ibritumomab tiuxetan (Zevalin, Spectrum) was approved for the treatment of patients with previously untreated follicular non-Hodgkin's lymphoma who achieve a partial or complete response to first-line chemotherapy.

A new branded version of interferon beta-1b (Extavia, Novartis) was approved for the treatment of relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations.

Azelastine nasal spray 0.15% (Astepro, Meda) was approved for the treatment of the symptoms of seasonal and perennial allergic rhinitis.

Pancrelipase delayed-release capsules (Zenpep, Eurand) were approved for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis (CF) or other conditions.

Bepotastine besilate ophthalmic solution 1.5% (Bepreve, ISTA) was approved for the treatment of ocular itching associated with allergic conjunctivitis in patients aged ≥2 years.