Replies to post #9190 on Momenta Pharmaceuticals, Inc. (MNTA)

[mouton29]

<<That’s correct—“at risk” generic launches (which are more common than some people realize,) require final rather than tentative FDA approval.>>

This article on the general subject explains it as follows:

If a brand name drug company files a patent infringement action with 45 days of receiving the Paragraph IV notice letter, it is entitled to an automatic 30-month stay of FDA "final" approval of the ANDA. As a result, FDA can only grant "tentative" approval of the ANDA, thereby preventing the generic company from marketing its generic drug during the stay. Assuming FDA is otherwise satisfied with the ANDA, it will make the "tentative" approval "final" upon the earlier of the expiration of the 30-month period or a court determination of patent non-infringement or invalidity.

https://docs.google.com/viewer?a=v&q=cache:35eEN1ajw2YJ:www.crbcp.com/pdf/MG%26WYC_Article.pdf+fda+tentative+approval+at+risk+launch&hl=en&gl=us&pid=bl&srcid=ADGEEShRKkHLbMPozyVEI0HQyvE6AC_9bYao0pCaROC1TpNsycuL9W6elrXJXQixgV8VgfS9eJ6v7xPqiIxQAY4C26xN6DAj9sa-UqyOksj7f2tJbPNg5qIgptBkKtXt25lbI7lqL-jX&sig=AHIEtbRTsXFVuY6RvdJlgLoHvdywF-tioA