Already the first month of the new year draws to a close. We’ve heard about the State of the Union, such that it is. The days, thankfully, grow longer. And at the FDA, there have been another huge batch of approvable letters issued this week. In addition to the letter issued to Wyeth this week, one was issued to Astellas. Combine that with the letters issued in late December and one can surmise that the rate of approvable letters is outstripping the rate of approvals. Are they being more cautious than ever before? Have standards been slowly changing? If so, it may be time for some communication from the agency along those lines:
- Astellas Gets Approvable Letter – Astellas announced that it received an approvable letter on two of three indications on its once daily immunosuppressant for transplant patients FK 506 (tacrolimus). The drug sought indications as a prophylaxis for organ rejection in heart, kidney and liver transplants, and got a non-approvable for heart and approvable for kidney and liver. The release did not reveal the nature of the questions raised by FDA.
- FDA Questions Efficacy of New Birth Control Pills – The news that new birth control pills may have a higher fail rate than the older versions because of a lower level of hormones made the waves this week when the FDA issued a statement.
Bear in mind, approvable letters are proprietary to the company. The FDA will generally not issue comment on approvable letters and the company may or may not announce it and/or the contents.
This weekend, the approvable letter resource in the column to your left will be updated. Have a good weekend everyone.