11. If that test confirms the U.S. study, the company could apply for a new drug approval from the U.S. Food and Drug Administration by early next year. 12. In the brave new world of accelerated drug approvals by the US Food and Drug Administration, the case of the diabetes medicine Rezulin is a cautionary tale. 13. Investors had expected Cor to analyze the results from the Phase III study during the second quarter, and file for a new drug approval later this year. 14. It also reverses an earlier effort by regulators and the drug industry to speed up drug approvals. 15. Pfizer spokesman Kate Robbins said the pharmaceutical company plans to file for a new drug approval with the U.S. Food and Drug Adminstration at the end of this year. 16. Sales have been flat but new drug approvals may help. 17. Schering has arranged to market Triquilar with Japanese firm Yamanouchi Pharmaceutical if the drug gains approval, Harenberg said. 18. Since the beginning of the year Teva has received six generic drug approvals in the United States. 19. Some of its efforts to speed federal drug approval have failed. 20. Speedier drug approvals leave fewer drug companies than usual waiting for a late December visit from the Santa at the Food and Drug Administration. |