Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Protamine sulfate intravenous solution, 50 Milligrams/5 Milliliters, not withdrawn from sale, (Jun 10, 2026)
By WK Editorial Staff
The drug products are no longer being marketed.
The FDA determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements (Notice, 91 FR 34634 (June 8, 2026)).
Dates. June 5, 2026.
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