By CAPosts 06 April, 2021 - 04:03pm 21 views
The Committee of New Molecules of the Federal Commission for the Protection against Sanitary Risks (Cofepris) issued a favorable opinion on Dapagliflozin and Empagliflozin, drugs for their expansion of therapeutic indication to prevent the deterioration of nephropathy.
© Provided by Milenio La Cofepris it did not elaborate on those biopharmaceuticals whose laboratories still have patents. (Archive)
"The drugs Dapagliflozin and Empagliflozin received unanimous favorable opinions from the experts for the expansion of their therapeutic indications, which should be included in their files and presented to the Health Authorization Commission for authorization to expand the therapeutic indication", from according to a statement.
The Committee for New Molecules (CMN) , which met this Monday, considered that the first Dapagliflozin molecule, presented by AstraZeneca, received a unanimous favorable opinion from experts for the extension of the therapeutic indication to prevent the deterioration of nephropathy. The second molecule under consideration was the drug Empagliflozin, presented by Boehringer Ingelheim Promeco, Cofepris reported that the drug Empagliflozin received a unanimous favorable opinion from the experts for the inclusion of a therapeutic indication for the prevention of hospitalizations due to heart failure.
"The decisions are part of the approval process required by Cofepris to meet the quality, safety and efficacy requirements necessary when considering a product."
And they are part of its process of optimization of the procedures of the Committee of New Molecules announced at the beginning of the month, it will continue to inform about the opinions and sessions, maintaining its commitment to be a transparent, efficient, innovative and reference institution.
Source : MSN