Tonix Pharma: FDA Affirms Alignment On CMC Content And Commercial Strategy For Tonmya

(RTTNews) - Tonix Pharmaceuticals (TNXP) announced receipt of the formal minutes from a recent pre-New Drug Application Type-B Chemistry, Manufacturing, and Controls meeting with the FDA for Tonmya for the management of fibromyalgia. The company believes it is aligned with the FDA on key topics, including proposed drug substance and drug product commercial specifications, shelf life assignment, manufacturing and commercial drug packaging. Also, the company has completed the second and final pre-NDA meeting for Tonmya with the FDA.

The company said it remains on track to submit the NDA for Tonmya for the management of fibromyalgia to the FDA in the second half of 2024.

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