FDA Greenlights Generics for Stomach-Coating Carafate Suspension
Published Date: 9/2/2026
Notice
Summary
The Food and Drug Administration (FDA, Agency, or we) has determined that CARAFATE (sucralfate) oral suspension, 1 gram (g)/10 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Generic Approvals Remain Allowed
On September 2, 2026, FDA determined that CARAFATE (sucralfate) oral suspension, 1 gram/10 milliliters, was not withdrawn from sale for reasons of safety or effectiveness. Because of this, FDA will not begin procedures to withdraw approval of ANDAs that refer to this product and will continue to approve ANDAs referring to the product so long as they meet legal and regulatory requirements; the product remains listed in the Orange Book ‘‘Discontinued Drug Product List.’
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