Drugs

FDA Denies Zydus Indomethacin Suppository Petition

FDA has denied a Zydus Pharmaceuticals (USA) 9/13/2023 petition asking the agency to take specified actions about indomethacin suppositories, 50 mg. Zydus is one of the manufacturers of this generic product.

The petition asked that FDA:

ensure that the currently marketed reference standard for the suppositories approved under the Iroko Pharmaceuticals ANDA 073314 complies with the International Conference on Harmonization (ICH) guidelines and established impurity acceptance criteria; and
ensure compliance as per ICH guidelines and established impurity acceptance criteria before approving any ANDA that only justifies higher impurity levels citing the results of the currently marketed reference standard without providing any adequate scientific justification for any higher impurity levels.

In its response, FDA says Zydus called for agency action “considering the risks presented by a high amount of unknown organic impurities in indomethacin suppositories.” The letter says Zydus did not present sufficient evidence that ANDA 073314 does not comply with the ICH guidelines and impurity acceptance criteria. It also points out that the impurities guidances provide multiple recommendations relating to impurity acceptance criteria.

“Those recommendations encompass scenarios when the impurities in an ANDA are below the recommended qualification threshold or when the ANDA sponsor provides an appropriate scientific rationale and safety data to support limits for impurities that exceed the recommended threshold,” FDA says. “Furthermore, even if the unknown organic impurities exceed the ICH guidelines in a hypothetical ANDA for indomethacin suppositories, 50 mg, such impurity levels may be acceptable for an ANDA for indomethacin suppositories … if information were to be submitted in the ANDA that supports the safety of the proposed impurities limit….”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome