The FDA approved Wyeth’s Pristiq (desvenlafaxine) to treat adult patients with major depressive disorder. Wyeth expects to begin shipping Pristiq to wholesalers beginning in the second quarter of 2008.
The FDA issued a non-approvable letter for the long-acting, injectable form of Eli Lilly’s top-selling drug Zyprexa, stating it needed additional information on excessive sedation that occurred in certain patients. Lilly is seeking approval of the long-acting form of the drug for use in certain patients with schizophrenia. The drug could be injected every two or four weeks. In February, an FDA panel of outside medical experts gave limited backing for the product and suggested the agency could approve it with restrictions.
The FDA approved three new dosage strengths of Endo Pharmaceuticals Opana ER (oxymorphone HCl) extended-release tablets CII. The new strengths — 7.5 mg, 15 mg, and 30 mg — will be available on April 1, 2008, and will join previously approved strengths of 5 mg, 10 mg, 20 mg and 40 mg. An opioid analgesic, Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
