Pharmacy Compounding Advisory Committee Votes Mostly In Unison
In first meeting after multi-year absence, FDA’s Pharmacy Compounding Advisory Committee takes 33 votes on do-not-compound and bulk substances lists.
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ANDAs mistakenly still are cataloged as approved even though they have been withdrawn from marketing.
OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.
Singulair’s Psychiatric AE Risks Still A Problem, But US FDA Has Limited Mitigation Options Remaining
Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.