InnoPharma Licensing LLC: Acetaminophen

FDA recommends hat the human-readable expiration date on the drug package label include a year, month, and non-zero day.

FDA recommends that the expiration date appear in YYYY-MM-DD format if only numerical characters are used or in YYYY-MMM-DD if alphabetical characters are used to represent the month.

FDA recommends that a hyphen or a space be used to separate the portions of the expiration date.

FDA recommends that the humanreadable expiration date on the drug package label include a year, month, and non-zero day.

If a 505(b)(2) application is submitted for a drug or method of using a drug claimed by a patent and the applicant has a licensing agreement with the patent owner, the applicant must submit a paragraph IV certification as to that patent and a statement that the applicant has been granted a patent license.

505(b)(2) application must contain a written statement from the patent owner that it has a licensing agreement with the applicant and that it consents to approval of the 505(b)(2) application as of a specific date.

Note that it is possible that, before your application is resubmitted and ready for full approval, another NDA for a singleingredient acetaminophen drug product may qualify for exclusivity that could affect the approval of your 505(b)(2) application; in such cases, you may submit a statement explaining why such exclusivity does not affect the approval of your application.

We also acknowledge receipt of your amendment dated November 3, 2016, which was not reviewed for this action.

1. You have not provided adequate nonclinical safety justification for the drug product formulation.

Satisfactory resolution of these deficiencies is required efore this application may be approved.

4. Under 21 CFR 314.54(a)(1)(vi), a 505(b)(2) application must contain a patent certification or statement with respect to any relevant patents that claim the listed drug or that claim any other drugs on which the investigations relied on for approval of the application were conducted, or that claim a use for the listed or other drug.

We remind you of your commitment in your August 8, 2016, submission to conduct longterm stability studies on the first three batches produced © and submit those to your NDA.