Replies to post #17345 on Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Applicants receiving a CRL have 12 months to respond to the FDA in one of three ways under § 314.110(b)(1)-(3):

Responding to the CRL by resubmitting–
The applicant can resubmit the application in its entirety, addressing each of the deficiencies described by the FDA in the CRL, using the suggested methods offered by the FDA in the CRL, or by applying the applicant’s own solutions. The significance of the changes to the application will grant the FDA from two to six months of additional application review time.

Withdrawal–The applicant can withdraw the NDA or ANDA in its entirety. Note that such a withdrawal is without prejudice and allows the applicant to refile an application.

Request an Opportunity for a Hearing–The applicant can request the opportunity to meet with the FDA to discuss whether there are grounds for denying the application under § 505(d) and (j). However, applicants should be warned that these hearings are open and public hearings, and granting the hearing does not bind the FDA to actually reconsider the application.

http://www.healthcarelawinsights.com/2015/01/fda-complete-response-letters-the-design-v-reality-of-fdas-responses-to-drug-applications/

[alternatepatel]

MYL CEO on Copaxone delay

Jami Rubin
So – but today as we sit here, generic Advair didn’t get approved. I haven’t heard anything on Copaxone. There has been a slowdown clearly in complex generic drug approval.

Heather Bresch
No question, there has been. I would tell you that we are working steadfastly to get these over the finish line. As far as Copaxone, on the 20 milligram, we very recently got an information request. We’re responding to that real time. I certainly would hope, as we’re here at the end of a quarter and coming into our earnings call, we’ll be able to bring you visibility and clarity on what that is, but I can tell you, we’re answering that.

Jami Rubin
So, you won’t get it approved in June?

Heather Bresch
I don’t – we could. We absolutely could. We got an information request. We’re responding to that. And so that would be totally in the FDA’s hands on this, but I can’t speak for them, but it could get approved.

Jami Rubin
So that, like can you tell us to of the nature of the information?

Heather Bresch
No. What I can tell you is that, we feel confident we can answer everything. As we’ve said, we had a CRL previously, we answered that in full. We received this information request, we’re confident to respond to that, like I said, very, very timely. And...

Jami Rubin
Does that require a meeting with the FDA?

Heather Bresch
No, not necessarily, it’s much more fluid in the sense that what they’ve asked for us getting to them, and then let us see where that takes it. It could lead to being able to be approved or it would require a discussion that is certainly not – it doesn’t necessarily dictate one.

Jami Rubin
So, did the action date actually come and go? The target date that’s...

Heather Bresch
So we have said that both the 20 and 40 were in June. And like I said, we recently got the information request on the 20.

Jami Rubin
Okay.

Heather Bresch
And we haven’t gotten anything yet on the 40.

Jami Rubin
So, does that actually resolve before the 40 is approved?

Heather Bresch
There are separate applications, it won’t necessarily – it doesn’t necessarily mean that.
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For older ANDAs, all FDA questions come in the form of a CRL.

What makes you say that? AFAIK IRs are different than CRs.