FDA actions in brief, August 2007

Key Points

FDA has approved armodafinil (Nuvigil, Cephalon) to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder.

A new formulation of progesterone (Endometrin Vaginal Insert, Ferring) was approved to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology treatment for infertile women.

A sugar-free oral formulation of levocarnitine (Carnitor SF, Sigma-Tau) was approved for the treatment of primary systemic carnitine deficiency and for acute and chronic treatment of patients with an inborn error of metabolism resulting in a secondary carnitine deficiency.

An oral suspension of fosamprenavir (Lexiva, GlaxoSmithKline) was approved for the treatment of HIV in pediatric patients.

A higher concentration of adapalene (Differin Gel, 0.3%, Galderma) was approved for the treatment of acne.

A foam formulation of ketoconazole 2% (Extina, Stiefel) was approved for the topical treatment of seborrheic dermatitis in immunocompetent patients aged ≥12 years.

FDA has approved new storage guidelines for glatiramer injection (Copaxone, Teva/Sanofi-Aventis) prefilled syringes, indicated for the reduction of the frequency of relapses in ambulatory patients with relapsing-remitting multiple sclerosis characterized by ≥2 attacks of neurologic dysfunction over the preceding 2-year period. The syringes may now be stored at room temperature for ≤1 month. Previously, this drug was approved for room temperature storage for ≤7 days.

A new formulation of clozapine (FazaClo Orally Disintegrating Tablets, Avanir) has been approved for the management of severely ill patients with schizophrenia who fail to respond adequately to standard schizophrenia drug treatments and for reducing the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at risk for suicide. The agent is now available in bottle packaging and in a new 12.5-mg strength.