Biotech Values

[genisi]

IJ, as I've wrote elsewhere, very similar language* appears in the warning letter that Teva received for its Irvine, California injectable facility, which was received in December 2009. Irvine problems have not resolved yet as evidenced by the Gemzar manufacturing agreement with APP ( #msg-59484534 ), but that didn't stop the FDA from approving Teva's ANDA for Sensipar on May 14th, 2010. Bottom line, I don't think that the warning letter will prevent additional approvals or other products unless produced at this facility.

* "FDA may withhold approval of requests for export certificates, or approval of pending new drug applications listing your facility, until the above violations are corrected."