IntelGenx Corp.: RizaFilm

Food, Drug, and Cosmetic Act for RizaFilm (rizatriptan) oral film 10 mg.

We acknowledge the out of specification (OOS) investigations submitted in response to the September 26, 2019, action letter.

Additionally, regarding INV-2019-017, in order to support disqualification of the OOS stability results obtained using © for analysis of this product, further investigation is needed to identify the root cause.

4) During the recent inspections of IntelGenx Corp. (FEI 3005721224) for oral film products, our field investigator observed objectionable conditions at the drug product manufacturing facility.

Please note that that this information will be reviewed by the Agency during the review of the application and a follow up Pre approval inspection may be needed to verify that the facility has taken necessary corrective actions to ensure oral film product quality.

If you resubmit this application, include draft carton and container labeling revised as ollows:

Additionally, to minimize confusion and reduce the risk for deteriorated drug medication errors, FDA recommends that the human-readable expiration date on the drug package label include a year, month, and non-zero day, if space permits.

The Act requires manufacturers and repackagers, respectively, to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction in(to) commerce beginning November 27, 2017, and November 27, 2018, respectively.

If you resubmit this application, include draft carton and container labeling revised as follows:

FDA recommends that 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 YY YY-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.

During recent inspections of the Po drug substance manufacturing facility) and Intelgenx Corp., (FEI: 3005721224, drug product manufacturing facility) for this NDA, our field investigators conveyed deficiencies to the representatives of the facilities.

October 31, 2017, which has been removed from the submission, but does not appear in the current version of this document submitted October 1, 2018.

9. In section 3.2.P.8.3, the long-term results for assay and impurities at approximately 2 months appear to be missing for the four batches manufactured at IntelGenx in 2018.

Provide this data, if available, and update the application accordingly.