View Full Version : FDA grading for generics


yamaustin
01-07-15, 02:59 PM
wasn't easy :-) but here it is. The FDA does grade the bioequivalence or therapeutic equivalence (TE) for generics, according to this:
A Drug products that FDA considers to be therapeutically equivalent (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#Therapeutic%20Equivalents) to other pharmaceutically equivalent products, i.e., drug products for which:
(1) there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or
(2) actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence. These are designated AB.
B Drug products that FDA at this time, considers NOT to be therapeutically equivalent to other pharmaceutically equivalent products, i.e.,drug products for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence. Often the problem is with specific dosage forms rather than with the active ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX, or B*.


Well, besides the downgrading of Mallinckrodt's extended release, no news for the much more common and widespread oral tablets, all are AB.

Surprise that their oral solution gets AA...



link:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm
enter methylphenidate or whatever you are looking for in the search box


http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm