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The FDA has approved Tonmya, the first new fibromyalgia treatment in over 15 years. This non-opioid, bedtime sublingual tablet (cyclobenzaprine HCl) offers faster absorption and significantly reduced daily pain in Phase 3

and enhance transparency and predictability of processes and decisions to build trust and confidence in the TGA's ability to ensure Australians have timely access to high quality, safe and efficacious products.[24] Time to PBS listing 2.25 The committee heard that, from a cancer patient's perspective, the critical timeline is that between regulatory approval of a cancer medicine by the TGA and its listing on the PBS

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Toxicology 238 , 192–199 (2007)