Replies to post #99148 on Biotech Values

[Mpower]

Dew, there is no letter, but the FDA will provide guidance on approvability....

Under section 505(j)(4)(A) of the act, within 180 days of the initial receipt of an ANDA, FDA must either approve or refuse to approve the ANDA, unless FDA and the applicant agree to an extension. If FDA refuses to approve the ANDA, it must give the applicant a notice of an opportunity for a hearing (NOOH) on whether the ANDA is approvable and will issue such a notice if the applicant elects to request a hearing rather than to amend or withdraw its application...