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Schwarz Pharma re-submits US Neupro application

Electronic applications for the rotigotine patch were submitted to both the FDA and the European Medicines Evaluation Agency (EMEA) on September 29, 2004. While the application form was

Merck reeling from Fosamax, Vioxx woes

In August 2003, a US District Court held Merck’s US patent for once-weekly administration of Fosamax (alendronate sodium) to be valid and infringed by Teva Pharmaceuticals’ abbreviated new

Wyeth antibiotic gets priority review status

A priority designation can be given to an new drug application (NDA) for Tygacil that, if approved, would be a significant improvement compared with existing treatments. Tygacil is

NTI anti-stroke drug fast-tracked

The fast-track designation will provide for expedited regulatory review for Viprinex (ancrod), which is under development for decreasing disability in patients with acute non-hemorrhagic stroke, treated within six