Biotech Values

[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.