Archive for December 2010
18
Delay On The Approval Of New Antiplatelet Drug
No comments · Posted by bjmdjd in FDA Alerts and News
The approval of a new antiplatelet drug which will eventually become a competitor with clopidogrel (Plavix) has been delayed by the Food and Drug Administration (FDA). The new drug, ticagrelor, was recently approved in Europe. The drug has received quite a bit of coverage in the lay press here in the U.S.
The FDA has asked for further evaluation of the PLATO trial which is a study conducted on 18,000 patients in 43 countries around the world to evaluate the new drug. In the 1,814 patients studied in the U.S. and Canada the outcome was worse in the patients taking ticagrelor as compared to clopidogrel (Plavix).
A spokesperson for drug company AstraZeneca says that the company remains confident that the drug will be approved. bjmdjd
Material modifications since posting: none
antiplatelet drug · AstraZeneca · clopidogrel · PLATO trial · Plavix · ticagrelor
I’m sorry I have been away for a few weeks but we buried my dear sweet mother this past Saturday. We had to be with her 24 hours a day since July due to her progressively worsening dementia. I certainly have a new admiration for caregivers. We are proud of the fact that we had the means and fortitude to allow her to die in her own den at home.
McNeil Consumer Healthcare, a division of Johnson & Johnson, has voluntarily recalled some Rolaids products in the U.S. and Canada due to possible product contamination.
The affected products in the U.S. include certain lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews. They also are recalling all lots of Rolaids Ultra Strength SoftChews and Rolaids Ultra Strength SoftChews plus Gas Relief distributed in Canada.
McNeil states that their investigation into the contamination occurred at a third party manufacturer. bjmdjd
Material modifications since posting: none
Johnson & Johnson · McNeil Consumer Healthcare · Rolaid products voluntary recall



