Shire submitted an NDA Aug. 24 for its attention deficit/hyperactivity disorder compound SPD503 (guanfacine) with the proposed trade name Connexyn. If approved, the drug would be the second non-stimulant product in its category. The company submitted another ADHD drug in July - SPD465 - designed to provide sustained release of medication for 16 hours. SPD465 has a May 21, 2007 standard review user fee date for treatment of adult ADHD; the agent has the same active ingredient as Shire's established Adderall brand (1Pharmaceutical Approvals Monthly August 2006, In Brief)...

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.