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Review Type: 351(k) BLA, Standard Review Submission Date: July 6, 2024 (Resubmission) Review Status: FDA previously issued a complete response letter in August 2022
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Fractures at diagnosis in infants and children with osteogenesis imperfecta
Visibly improves fine lines and wrinkles
The article names constipation lasting more than three to five days despite home measures, or accompanied by severe abdominal pain, distension, or loss of appetite, as reasons for immediate provider contact, since these can signal bowel obstruction or other complications
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