Oct 17 Some U.S. deadlines for reviewing new
drugs have come and gone without a decision from the Food and
Drug Administration. [ID:nN02287148]
Here is a list of some of the drugs and their status:
-- prasugrel, a blood thinner from Eli Lilly (LLY.N) and
Daiichi Sankyo (4568.T). A decision was due Sept. 26. The
application remains pending.
-- Promacta, a GlaxoSmithKline Plc (GSK.L) drug for a
clotting disorder. The deadline was Sept. 19. No decision has
-- Nplate, a clotting disorder drug from Amgen Inc
(AMGN.O). A decision was due July 23. The drug was approved
-- Telavancin, an antibiotic from Theravance Inc THRX.O.
No ruling was made at the deadline of July 21. The drug is now
scheduled to go before an FDA advisory panel on Nov. 19.
-- Entereg, a GlaxoSmithKline and Adolor ADLR.O drug to
treat a complication of bowel surgery. The product was approved
on May 20, which was 10 days after the May 10 deadline.
-- Cimzia, UCB SA's (UCB.BR) treatment for the bowel
disorder Crohn's disease. The deadline was March 30, and the
drug was approved April 22.
-- Lexiscan, a heart-imaging agent from CV Therapeutics
CVTX.O and Astellas Pharma (4503.T). A decision was due March
14, and it was approved on April 10.
-- Kynapid, an atrial fibrillation treatment from Cardiome
Pharma Corp (COM.TO) and Astellas. A ruling was expected Jan.
19. The companies said in August they had received an FDA
"approvable letter" requesting more information.
Also, Takeda Pharmaceutical Co (4502.T) has announced the
FDA will miss the Oct. 27 target date for diabetes drug
Source: Drugmakers, FDA
(Reporting by Lisa Richwine, editing by Tim Dobbyn)