Second Approval Letter for New ADHD Drug

New River Pharmaceuticals and Shire plc say they received a second approvable letter from the U.S. Food and Drug Administration for VYVANSE, lisdexamfetamine dimesylate, for the treatment of Attention Deficit Hyperactivity Disorder, or ADHD.

An approvable letter informs the PMA (Premarket Approval Applications) applicant that FDA has completed the scientific review and determined that the PMA can be approved pending resolution of minor deficiencies identified in the letter or during FDA's inspection of the device's manufacturing facilities.

New River and Shire now said that FDA hasn't requested any additional studies as a condition for approval of VYVANSE. The data requested are routine. VYVANSE is expected to be launched in the second quarter of 2007. The companies noted that the proposal of FDA that VYVANSE, which was earlier known as NRP104, be classified as a Schedule II controlled substance has been submitted to the U.S. Drug Enforcement Administration, or DEA.

Upon the FDA approval and receipt of final scheduling designation by DEA, VYVANSE would be available in three dosage strengths, such as 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

VYVANSE is considered to be a successor to Shire's Adderall XR, which loses patent protection in 2009. Meanwhile Shire believes the drug have the capacity to generate sales of over $1 billion a year.

On August 14, 2006 Shire announced that it had settled all pending litigation with Barr Laboratories, Inc. regarding Barr's Abbreviated New Drug Application and its attempt to market generic versions of Shire's ADDERALL XR for the treatment of ADHD. Barr will not be permitted to market a generic version of ADDERALL XR in the United States until April 1, 2009, except under certain limited circumstances, such as the launch of another party's generic version of ADDERALL XR.