Biotech Values

[dewophile]

Teva characterized the FDA-cited deficiencies in its Lovenox ANDA as “minor"

actually teva did not characterize the deficiencies as minor. they stated that the letter they received is called a minor deficiency letter.

here is the PR again:


Teva Pharmaceutical Industries Ltd announced today that it has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s abbreviated new drug application (ANDA) for generic Lovenox® (enoxaparin sodium) injection. The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has completed its review of the ANDA including the Company's responses to key questions during the review process. [this was added imo to imply that the "key" questions were reviewed and what is left is not as material
all in all a clever PR