October 17, 2008 / 5:34 PM / 9 years ago

FACTBOX-US regulators missing drug review deadlines

Oct 17 (Reuters) - 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 been made.

-- Nplate, a clotting disorder drug from Amgen Inc (AMGN.O). A decision was due July 23. The drug was approved Aug. 22.

-- 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 alogliptin. Source: Drugmakers, FDA (Reporting by Lisa Richwine, editing by Tim Dobbyn)

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