The accompanying table (click on image to enlarge) presents an updated calendar of expected FDA decision dates. Surprisingly, the FDA issued a complete response letter to Abbott Labs (ABT) for Vicodin CR, an extended-release version of the widely used painkiller that the company expected to be approved this quarter. Three more companies face key FDA decision in the month of December for abuse-resistant forms of opiate pain drug candidates. King Pharma (KG) and Pain Therapeutics (PTIE) await a decision on Remoxy while Alpharma (ALO) has applied for approval of Embeda. Also, Alpharma has rejected an unsolicited $1.6B bid by King Pharma, which extended the date of the tender offer until 21-November.
$8.7 (10/22/08)
