Rifampin Capsules Cleared for Generics by FDA
Published Date: 8/19/2025
Notice
Summary
The FDA says RIFADIN capsules (150 mg and 300 mg) weren’t pulled from the market because of safety or effectiveness problems. This means generic versions can keep getting approved as long as they meet safety rules, especially about tiny impurities. Patients and drug makers can keep counting on these meds without any sudden changes or extra costs.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
RIFADIN Capsules Stay Available
You can keep using RIFADIN (rifampin) capsules, 150 mg and 300 mg, because FDA determined they were not withdrawn from sale for reasons of safety or effectiveness. That availability is conditional on the drugs being manufactured or formulated so they satisfy any applicable acceptable intake limit for nitrosamine impurities.
Generic Approvals Can Continue
Drug makers can continue to get abbreviated new drug application (ANDA) approvals that refer to RIFADIN 150 mg and 300 mg because FDA will not start withdrawing those ANDA approvals. Continued approvals are allowed only if the products meet legal and regulatory requirements, including satisfying any applicable acceptable intake limit for nitrosamine impurities.
Nitrosamine Limits Required for Approval
FDA will allow the products to remain on the market and allow ANDA approvals only to the extent the drugs can be manufactured or formulated to satisfy any applicable acceptable intake limit for nitrosamine impurities. That requirement focuses regulatory approval on meeting acceptable intake limits for nitrosamine impurities.
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