This approval comes with a post-marketing requirement
from the FDA to assess the cardiovascular safety of EVENITY in postmenopausal osteoporosis women.
Pfizer on February 19 said it has taken steps to transition rheumatoid arthritis study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily in the FDA post-marketing requirement
This Phase IIIb/IV clinical study, comprised of 12,000 patients, is being conducted over a 5-year period in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group and is intended to address the post-marketing requirement
from the U.S.
Pfizer announced the company has taken steps to transition rheumatoid arthritis study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily in the Food and Drug Administration post-marketing requirement
The trial is a post-marketing requirement
(PMR) that was requested by the US Food and Drug Administration (FDA) to evaluate MACE for up to three years with aclidinium bromide.
The study was a post-marketing requirement
by the U.S.
ApoPharma, part of the Apotex group, has agreed to several post-marketing requirement
and commitments, including further study of Ferriprox in patients with sickle cell disease who have transfusional iron overload.