FDA Greenlights Generics for Gallstone Drug After Safety Check
Published Date: 5/30/2025
Notice
Summary
The FDA says ACTIGALL 150 mg capsules weren’t pulled from the market because of safety or effectiveness problems. This means drug companies can now get approval to make and sell generic versions of this medicine, as long as they follow the rules. Patients and pharmacies can expect more affordable options soon without any safety worries!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA OKs Pathway for Generics
The FDA determined that ACTIGALL (ursodiol) capsule, 150 milligrams, was not withdrawn from sale for reasons of safety or effectiveness. Because of that determination, the FDA can approve abbreviated new drug applications (ANDAs) for ursodiol 150 mg if all other legal and regulatory requirements are met.
More Affordable Options Expected
The notice says patients and pharmacies can expect more affordable options for ACTIGALL (ursodiol) 150 mg because the FDA can now approve generic versions, and the agency found no safety or effectiveness reason the branded product was withdrawn.
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