The U.S. FDA granted Mylan Pharmaceuticals Pvt. and
Biocon a three-month extension to get their approvals for selling a biosimilar
of a Roche breast cancer drug, according to a Bloomberg article. FDA told Mylan
it will extend the target action date for the Trastuzumab drug application to
Dec. 3, 2017.
The extension resulted from a European drug regulator
requesting Biocon to withdraw applications for Trastuzumab and Pegfilgrastim
until the company completed requirements of a re-inspection of its
manufacturing plant in Bengaluru, India, the story said. Earlier this month,
the U.S. FDA had also found 10 quality offenses at the Bengaluru plant.
Read the Bloomberg
article
0 comentários:
Postar um comentário