Replies to post #107362 on Biotech Values

[rwwine]

"I mean, if they are that different then why hasn't the FDA rejected it outright?"

I am wondering the same thing. Why then if TEVA and the manufacturing partner have not met the criteria for "sameness"......hasn't the FDA rejected the application?????? Perhaps I am missing something?

[DewDiligence]

…if they are that different then why hasn't the FDA rejected it outright?

For the reason that was previously discussed on this board: the FDA very rarely issues a formal rejection of an ANDA.

Note: the FDA has not even formally rejected the Lovenox ANDA from Amphastar despite the fact that Amphastar’s public actions reveal the ANDA to be hopeless.