Biotech Values

[DewDiligence]

Any news on TEVA?

We can be assured that Teva is not getting approval today. If they were, the FDA would surely not have issued a PR with the wording in http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm .

Other than that, we don’t know when—or if—Teva will get FDA approval. However, I think it’s reasonable to surmise that the FDA would have acted on both companies’ ANDA’s at the same time if Teva were close.

Moreover, Teva has argued from day one that approval of generic Lovenox should merely require characterization of FXa and FIIa rather than the multitude of ingredients that are constituents of branded Lovenox. Inasmuch as Teva is surely capable of characterizing FXa/FIIa, it’s reasonable to infer that the FDA wants more than that—presumably full characterization.