A REGULATORY STRATEGY AT THE TIME OF AN ANDA SUBMISSION FOR A SOLID ORAL DOSAGE FORM BY MANUFACTURING ONE SMALL SCALE BATCH AMONG THE THREE EXHIBIT BATCHES MAY BRING COST SAVINGS IN ADDITION TO PREVENTING POTENTIAL REFUSE TO RECEIVE FROM THE FDA

Author(s): Harinath Reddy Gangasani* and Nataraj. K. S.

Abstract: Generic Drug Manufacturers (Applicants) submit an Abbreviated New Drug Application (ANDA) to the FDA based upon an innovator Drug or an RLD (Reference Listed Drug). [1] Many ANDAs get rejected without making it past the first obstacle (acceptance of the application). The Agency can refuse to receive (RTR) an ANDA based on one major deficiency or ten minor deficiencies. [2] The FDA refused to receive on average about 17% of all original ANDAs from 2013 through 2018 in accordance with the requirements outlined in the RTR Guidance. Among the many reasons for RTRs, the FDA will RTR an ANDA if the applicant does not package a minimum (threshold) amount of the finished drug product in the container/closure systems that are proposed for marketing, as discussed in FDA’s guidance for industry ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers[3]. The threshold amount that should be packaged is governed by the specific dosage form. This article highlights “Batch Sizes and Packaging Amount Considerations for ANDA Submissions for solid oral dosage forms”, since the requirements outlined in the guidance document present varying interpretations and may sometimes result in RTR if one of the three exhibit batches were not fully packaged. In this article, the author elaborates the advantages when the applicant proposes one small scale batch among the three primary batches to be manufactured for the original ANDA submissions.

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