FDA Solicits Bids For Levothyroxine Stability Testing
This article was originally published in The Pink Sheet Daily
Executive Summary
Some manufacturers have been unable to demonstrate that their products have a two-year shelf life, the agency said.
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The potency specifications for the troubled levothyroxine should be narrowed from 90-110% to 95-105%, committee members recommend.
Levothyroxine Potency Specs Should Be Narrower, Joint FDA Advisory Cmte. Says
The potency specifications for the troubled levothyroxine should be narrowed from 90-110% to 95-105%, committee members recommend.
Levothyroxine Potency Standards To Be Addressed By FDA Advisory Committees
FDA is focusing on potential “clinically significant concerns” and will address intraproduct issues before moving to questions of bioequivalence.