FDA Drugs: January 2007

2007: Mar | Feb | Jan . . . 2006: Dec | Nov | Oct | Sep

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FDA Drugs: January 2007

• Vynase (now Vyvanse) gets approvable letter: New River Pharm and Shire are poised to release a new ADHD drug, lisdexamfetamine (was NRP-104).
• Generic Wellbutrin XL approved: by Anchen Pharma.
• Wellbutrin Package Insert was modified: to reflect the following additional info regarding its use in people with renal failure: "An inter-study comparison between normal subjects and patients with end-stage renal failure demonstrated that the parent drug Cmax and AUC values were comparable in the 2 groups, whereas the hydroxybupropion and threohydrobupropion metabolites had a 2.3- and 2.8-fold increase, respectively, in AUC for patients with end-stage renal failure." Also added was mention of double vision and increased intraocular pressure as reported adverse reactions.
  
• FDA releases Guidance on Pharmacogenetic data. The FDA released definitions for genomic biomarkers, pharmacogenomics, and pharmacogenetics.
• Alexza is working on Schizophrenia Agitation drug: The drug is an inhaled form of loxapine, a typical antipsychotic.
• New Antidepressant: Pristiq. Wyeth, who makes Effexor XR (venlafaxine), received an approvable letter for Pristiq (desvenlafaxine succinate), which is a metabolic derivative of Effexor; both drugs are serotonin-norepinephrine reuptake inhibitors (SNRIs). Approvable letters have conditions which must be met before the product can be marketed. The Wyeth facility in Puerto Rico must pass FDA's muster, and the marketing plan must be approved, prior to its release for the Major Depression indication. Wyeth is also going after an indication for Vaso-Motor Symptoms (VMS) related to menopause ("hot flashes" in English).