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For its second application, the FDA set a PDUFA date of May 14, 2024, but this was pushed back by three months after Ascendis filed a major amendment to the application

"The Oral Bioavailability of Vitamin B12 at Different Doses in Healthy Indian Adults"

Its primarily found in the modern diet in animal products, so vegans and vegetarians need to supplement with B 12 regularly

We believe this timeframe will provide sufficient time for hospitals, REHs, and ASCs to assess the impact on quality reporting without disrupting operational and care needs

Managing folate and B12 levels is crucial for women trying to conceive