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 the product's safety, effectiveness, and/or optimal use. These Postmarketing Commitment (PMC) studies build upon the data that was submitted for approval.
To view Pharmacyclics LLC Postmarketing Commitments, click here.
The PMC Summary Table includes our active Postmarketing Commitments and provides the following information, organized alphabetically by product name:
- Name of Product
- NDA Number
- Description of Commitment
- Date Commitment Given
- Projected Completion Date
- Commitment Status
Please note that the status and/or number of Pharmacyclics Postmarketing Commitments shown on the FDA website may differ from the information displayed on our PMC Summary Table because of 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 Pharmacyclics 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 should not be completed, or if Pharmacyclics 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 nonclinical (nonhuman), clinical (medical), and epidemiological studies that Pharmacyclics 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 PMCs, or PMCs for products for which Pharmacyclics does not hold the US regulatory approval.