Replies to post #125429 on Biotech Values

[DewDiligence]

The FDA would be saying that while the drug is not actually "the same" as enox, they are nevertheless approving it without any clinical trials to prove safety and efficacy.

We went through this discussion one year ago—see #msg-53397461.

As noted in that post, Teva may already have conducted—or may now be conducting—a clinical trial to obtain FDA approval for a non-substitutable Lovenox knockoff. Even if Teva has not conducted any such trial, it’s within the FDA’s statutory powers to approve an ANDA and designate the drug not therapeutically interchangeable with the reference product (branded Lovenox in this instance).

[DewDiligence]

As noted in #msg-66390512, the five sameness criteria for generic Lovenox are necessary for FDA approval, but they might not be sufficient.