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Conjugated estrogens

Executive Summary

FDA hopes to have revised guidance on in vivo bioequivalence studies for conjugated estrogens out by the end of the year. Draft was issued on June 16 ("The Pink Sheet" June 26, p. 5). However, FDA said issuance of revised guidance may be delayed if the agency decides document should be reviewed by Fertility and Maternal Health Drugs Advisory Committee, which is next scheduled to meet Feb. 1-2. Guidance was discussed at Oct. 20 meeting between FDA and Able Labs. Able said it is doing groundwork for in vivo bioequivalence studies and that FDA advised it to wait for the guidance before proceeding further. FDA previously had rejected Able's urinary excretion-based ANDA for estrogens.

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