Therakind Limited: Jylamvo

Please refer to your new drug application (NDA) dated and received March 1, 2021, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Jylamvo (methotrexate) oral solution.

Satisfactory resolution of these objectionable conditions is required (e.g., preapproval inspection and/or adequate facility responses addressing these conditions) before this application may be approved.

If it is determined that an inspection is needed to approve your application, please note that FDA continues to monitor the public health situation as well as travel restrictions.

2. Include the test for Deliverable Volume per USP <698> "Deliverable Volume' in the drug product specifications.

12, 2019 and for batch THE/20/0604 manufactured on February 2, 2020.

8. Include the following statement in your post approval stability commitment: Withdraw from the market any batches found to fall outside the approved specifications for the drug product.

If the applicant has evidence that the deviation is a single occurrence that does not affect the safety and efficacy of the drug product, the applicant should discuss it with the agency as soon as possible and provide justification for the continued distribution of that batch.

10. Submit your November 18, 2021 draft carton and container labeling based on our proposed revisions dated, November 12, 2021.

'ake before the application may be approved.