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Limitations: FDA rejected the Barth syndrome NDA in 2021 on efficacy grounds

All products sold by Loti Labs carry research use only designation, restricting use to laboratory for in-vitro testing and approved preclinical research

The TGA said it had been alerted to "severe allergic reactions" that had led to hospitalisation, severe inflammation, full-body intense itching, palpitations, pain, insomnia, blurred vision and musculoskeletal injuries