Shire's next-generation attention deficit/hyperactivity disorder drug Vyvanse (lisdexamfetamine dimesylate) clears FDA Feb. 23. The company will attempt to transition patients from Adderall XR to the new formulation before 2009, when Adderall generics are likely to launch. Vyvanse received a second "approvable" letter Dec. 21, but Shire had expected approval by March (1Pharmaceutical Approvals Monthly January 2007, p. 16). Indicated to treat children ages six to 12, the drug was evaluated in that age group in three dosage strengths (30 mg, 50 mg and 70 mg) in a 290-patient Phase III randomized, double-blind, placebo-controlled trial. Vyvanse is the first product to be approved following FDA's Feb. 21 announcement that manufacturers of 15 ADHD drugs would need to include patient medication guides to warn of possible cardiovascular and psychiatric risks...

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.