Pharma

Your Article Summary

See Latest Articles

Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDAs BYETTA(R) Injection Update
Amylin Pharmaceuticals, 11/03/09

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company issued the following statement in response to the U.S. Food and Drug Administration update on BYETTA injection. "The FDA update issued today aligns with the BYETTA label approved last week. The current label reflects the understanding of post–marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions. There is no evidence from preclinical and clinical studies that BYETTA has any direct toxic effect on the kidney," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals.

Today in Regulatory Issues...keeping you current

Receive free subspecialty "5-minute updates" via email

Tricare contracts may be re-bid after losing plans protest
American Medical News , 11/25/09

GSK Regulatory Update: Avodart
GlaxoSmithKline, 11/24/09

Baytubes carbon nanotubes in marine coatings help reduce frictional resistance
BayNews International, 11/24/09

 See all of Regulatory Issues