Generics May Have Tmax Flexibility, FDA Says
This article was originally published in The Pink Sheet Daily
Several hours of Tmax difference between brand Wellbutrin XL and generic bupropion is not critical to the drug’s efficacy given that it can take weeks to reach the drug’s desired effect, FDA determined.
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In what appears to the first downgrade of a generic equivalency based on patient complaints, FDA changes the high dose of the Teva/Impax product from AB to BX. The four other generic manufacturers of 300 mg bupropion extended-release must conduct their own bioequivalence tests, but FDA does not expect problems because they are differently formulated than the Teva/Impax version.
Focusing on orphan-first drugs may be best route to address pricing concerns, Health Affairs study suggests after finding that just one-fifth of spending on 15 top-selling partial orphan drugs was for the drugs’ rare disease indications.
US Remains Conservative On Vaccine Dosing Regimens As CDC’s ACIP Highlights Minimal Comfort With Relying On Unproven Correlates
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices concerns about making COVID-19 vaccine dose regimen changes based on unproven immune correlates of protection could be a warning sign to sponsors about roadblocks they might face if updating vaccines to address viral variants or conducting pediatric studies relying on such surrogate endpoints.