Complete Response Letters
Metacel Pharmaceuticals, LLC: Ozobax
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 25, 2018
It was clearly stated in the January 11, 2017, Complete Response Letter, item #7, that if the identity, assay, or related substance method has to be modified to be fully validated, drug product samples may require retesting.
CRL_NDA208193_20180625:p1:s18Therefore, you should place an additional 2 batches of the drug product on stability, according to ICH Q1A (R2), and submit sufficient long-term stability data to support the proposed shelf life.
CRL_NDA208193_20180625:p1:s20We recommend using a format like either DDMMMYYYY (e.g., 31JAN2013), MMMYYYY (e.g., JAN2013), YYYY-MMM-DD (e.g., 2013JAN-31), or YYYY-MM-DD (e.g., 2013-01-31).
CRL_NDA208193_20180625:p2:s2Complete Response Letter, Jan 11, 2017
We also acknowledge receipt of your amendment dated October 14, 2016, which was not reviewed for this action.
CRL_NDA208193_20170111:p1:s16The proposed manufacturing and control strategy for Ozobax (baclofen oral solution) is inadequate to assure the identity, purity, strength, and quality of the commercial drug product.
CRL_NDA208193_20170111:p1:s21More Complete Response Letters
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