Following approval of a drug or biologic product, the U.S. Food and Drug Administration (FDA) may request and/or require the sponsoring company to conduct further studies that are designed to gather additional information about a product’s safety, effectiveness, and/or optimal use. These postmarketing commitment (PMC) studies build upon the data that was submitted for approval.
This website contains Abbott’s U.S. postmarketing commitments. Click here to view Abbott’s PMC Summary Table.
Our PMC Summary Table includes all active postmarketing commitments and provides the following information, organized alphabetically by product name:
- Name of Product
- NDA/BLA Number
- Description of Commitment
- Date Commitment Given
- FDA Projected Completion Date
- Commitment Status
Please note that the status and/or number of Abbott’s postmarketing commitments shown on the FDA website may differ from the information displayed on this site based on the timing of content review and website updates. The status categories used in the PMC Summary Table are consistent with categories used by the FDA.
Information about Abbott’s PMCs will be updated twice a year, to reflect new commitments as well as the progress we have made in fulfilling our existing postmarketing commitments. Once the FDA determines a PMC is fulfilled, or they release Abbott from a commitment, or if Abbott terminates a study before completion date, those PMCs will be removed from our PMC Summary Table.
The PMCs listed in the PMC Summary Table include preclinical (nonhuman), clinical (medical), and epidemiological studies that Abbott has agreed to conduct to gather additional information about the safe and effective use of our approved products. This website does not contain technical chemistry, manufacturing and controls (CMC) PMCs, or PMCs issued by FDA for products where Abbott does not hold the US regulatory approval.
Note: All data reflects Abbott activities in 2012. Some content has been adjusted to remove data specific to AbbVie, which became a separate company on Jan. 1, 2013.