FDA hands out two key regulatory approvals

Two big regulatory wins for developers were announced this morning. The FDA has approved Shire's Vyvanse for ADHD, giving the company a successor to Adderall [1]. And Eli Lilly's Cymbalta won approval as a therapy for generalized anxiety disorder.

Vyvanse is amphetamine based, but only becomes effective after it enters the digestive tract. The company says that the digestive trigger mechanism should make the drug less liable for abuse by users who snort or inject pills. Cymbalta, which is already approved for depression and numbness in the limbs, is an SNRI drug, a class that includes Effexor.

- see the press release [2] on Vyvanse
- check out this release [3] on Cymbalta
- read the MarketWatch report [4] on Cymbalta

Related Articles:
Lilly seeks Cymbalta approval, bullish on 2006. Report [5]
Shire gambit aimed at delaying generic Adderall XR. Report [1]