Replies to post #116368 on Biotech Values

[mouton29]

<<Then, two weeks ago, Teva disclosed that it had received an FDA Warning Letter regarding contamination issues at its Jerusalem oral solid dosage plant. While this plant is not involved in manufacturing generic Lovenox, the Agency wrote, “Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with [Current Good Manufacturing Practice regulations], FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer.”>>

So by that logic, sometime shortly after problems at the Jerusalem ORAL plant are fixed, all outstanding TEVA applications and supplements on all drugs - whether related to that plant or not -- will be approved. How many applications is that, and wouldn't it make TEVA the buy of the century (or perhaps, human history)?

[10nisman]

While this plant is not involved in manufacturing generic Lovenox, the Agency wrote, “Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with [Current Good Manufacturing Practice regulations], FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer.”

zipjet, you're basing your tL approval guess based on this statement? How does this have any relevance to FDA approval of tL? It does not involve manufacturing of generic Lovenox, second the FDA said it may withhold approval not that it is or was withholding new applications or supplements.

[jq1234]

“Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with [Current Good Manufacturing Practice regulations], FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer.”

If this were the only thing holding tL approval back, FDA would not have sent separate deficiency letter on tL in Jan.

[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."