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FDA Approvals - Promoting Off-Label Uses of Approved Drugs: Green Light or First Amendment


Promoting Off-Label Uses of Approved Drugs: Green Light or First Amendment Violation? (Psychiatric Times)
The FDA recently released its long-awaited but highly controversial final guidance permitting drug and device manufacturers to distribute medical journal articles and medical or scientific texts that discuss off-label uses of approved products.

Jubilant Organosys gets US FDA approval for Draximage Sestamibi (PharmaBiz)
Jubilant Organosys's US based subsidiary Draximage LLC has received US FDA approval for its ANDA for Draximage's generic Sestamibi. The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite.
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