Lilly Strattera Is First ADHD Agent With Adult Indication, Full-Scale Launch
Executive Summary
Lilly's Strattera will be the first ADHD therapy to have a traditional full-scale pharmaceutical launch
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Pfizer Lyrica Launch Awaits Controlled Substance Scheduling
Pfizer's launch of Lyrica will be delayed while pregabalin undergoes controlled substance scheduling at the Drug Enforcement Administration
Pfizer Lyrica Launch Awaits Controlled Substance Scheduling
Pfizer's launch of Lyrica will be delayed while pregabalin undergoes controlled substance scheduling at the Drug Enforcement Administration
Quarterly Earnings Calls, In Brief
Novartis Prexige advisory committee?: Novartis Prexige gastrointestinal and cardiovascular safety study on COX-2 inhibitor could be subject of FDA advisory committee meeting next year, Global Pharma Development Head Joerg Reinhardt, PhD, tells analysts July 21. Final results from 18,000-patient TARGET study will be available in early 2004 (1"The Pink Sheet" Nov. 21, 2001, p. 32). FDA's arthritis committee reviewed similar outcomes studies for Pfizer's Celebrex and Merck's Vioxx in 2001 (2"The Pink Sheet" Feb. 12, 2001, p. 6). Novartis has not yet heard whether the Prexige (lumiracoxib) NDA will be the subject of committee review. Prexige's user fee deadline is in late September...