Much faster than I expected!
"Dear Ms. Chen,
I am writing in regards to comments made by Teva executives that
suggest approval of their generic enoxaparin is imminent. Such
comments had two facets: 1) that approval was imminent because their
immunogenicity data was submitted one month after Momenta's, and 2)
that they believed they had met the 5 criteria detailed in the FDA's
response to Sanofi's citizen's petition concerning generic enoxaparin.
It seems to me one could get a more accurate idea of when the approval of Teva's enoxaparin by asking Teva management these two questions, which, to my knowledge have not been asked on public calls.
1) Has the FDA inspected the facilities and production lines you will use for the manufacture of your enoxaparin, and if so, did those facilities pass said inspections?
2) Has the FDA inspected the facilities used to manufacture your
source material (i.e. those of your suppliers of porcine intestinal
mucosa and heparin), and if so, did those facilities pass said
inspection?
We know that if the FDA has not completed these inspections to its
satisfaction, approval is not imminent. Put another way, it was at
least six months after these inspections were conducted at Momenta
that the FDA approved their ANDA.
I and others have tried contacting Teva with these questions, and we
have gotten no response. I was hoping that you might be able to ask
these questions of Teva yourself, either privately or in the next
public forum where it can be done. We are thinking that someone in
your position might get a better response. If we somehow missed this being asked and answered, we'd really appreciate being enlightened as to what the answer was.
Thank you very kindly for your time and attention.
Sincerely, " . . .
Her terse reply: "Sure thanks! Yes I will ask these questions."
Which implies she hasn't seen heard of that being asked and answered, either. If I get further contact from her, I'll say so. Otherwise . . . when is Teva's next CC? Can't be much more than a month from now.
Obviously, I don't have a grammar checker running; Ms. Chen didn't waste time on the slight garbling in the second paragraph.
Regards, RockRat
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