Replies to post #329873 on Amarin Corp Plc (AMRN)

[lizzy241]

sleven, it's been 214 days since approval for dr. reddys gv dated 8/7/2020.
this info is from your prior link.

Postmarketing reporting requirements for this ANDA are set forth in 21 CFR 314.80-81
and 314.98 and at section 506I of the FD&C Act. The Agency should be advised of any
change in the marketing status of this drug or if this drug will not be available for sale
after approval. In particular, under section 506I(b) of the FD&C Act, you are required to
notify the Agency in writing within 180 days from the date of this letter if this drug will not
be available for sale within 180 days from the date of approval. As part of such written
notification, you must include (1) the identity of the drug by established name and
proprietary name (if any); (2) the ANDA number; (3) the strength of the drug; (4) the
date on which the drug will be available for sale, if known; and (5) the reason for not
marketing the drug after approval.
PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and
promotional labeling materials prior to publication or dissemination. Please note tha

[sts66]

That does not say what you think it says (in order to keep the ANDA) - it does NOT require the FDA to pull back an ANDA if the generic is not marketed within 180 days of the ANDA approval, rather the FDA simply wants an explanation why it's not on sale - and "we can't source enough API to launch" is a rationale answer.

Postmarketing reporting requirements for this ANDA are set forth in 21 CFR 314.80-81 and 314.98 and at section 506I of the FD&C Act. The Agency should be advised of any change in the marketing status of this drug or if this drug will not be available for sale
after approval. In particular, under section 506I(b) of the FD&C Act, you are required to
notify the Agency in writing within 180 days from the date of this letter if this drug will not
be available for sale within 180 days from the date of approval. As part of such written
notification, you must include (1) the identity of the drug by established name and
proprietary name (if any); (2) the ANDA number; (3) the strength of the drug; (4) the
date on which the drug will be available for sale, if known; and (5) the reason for not
marketing the drug after approval.

Don't know why you keep getting this ANDA stuff wrong - it's almost like you want the words to support your argument so much you see things that aren't there.