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FDA Approval Notes:

The U.S. Food and Drug Administration (FDA) evaluates new drug applications based on a balance of efficacy and safety data. Given that TNX-102 SL has demonstrated significant efficacy in relieving fibromyalgia symptoms and has good safety, it is expected to receive FDA approval.

In addition, the FDA has granted TNX-102 SL fast track qualification to accelerate the review of drugs for treating serious diseases and meeting unmet medical needs.