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Recent FDA actions center on endocrine drugs
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Endocrine Today has compiled a list of recent FDA news stories relating to endocrine practice. Drugs under consideration included those for osteoporosis, diabetes, overweight and obesity, hypoactive sexual desire disorder and hypogonadism.
FDA approves romosozumab for osteoporosis
The FDA approved the monoclonal antibody romosozumab (Evenity, Amgen) to treat osteoporosis in postmenopausal women at high risk for fracture, according to a press release from the agency. E. Michael Lewiecki, MD, FACP, FACE, offers perspective.
FDA issues complete response letter for sotagliflozin
The FDA issued a complete response letter declining to approve a new drug application for oral sotagliflozin (Zynquista), a first-in-class dual SGLT1 and SGLT2 inhibitor for adult with type 1 diabetes, according a press release from Sanofi and Lexicon. Anne L. Peters, MD, offers perspective.
FDA approves hydrogel pill for overweight, obesity
The FDA approved an oral hydrogel therapy (Plenity) that induces feelings of fullness without adding calories for adults with overweight and obesity, according to a press release from Gelesis. Caroline Apovian, MD, offers perspective.
FDA orders label change allowing some alcohol use with flibanserin
The FDA issued a safety labeling change order to Sprout Pharmaceuticals for the serotonin receptor agonist flibanserin (Addyi), ordering a modification to the boxed warning that states alcohol use is contraindicated when taking the drug. Sheryl Kingsberg, PhD, offers perspective.
FDA approves oral testosterone capsule for men with hypogonadism
The FDA approved testosterone undecanoate in an oral capsule (Jatenzo, Clarus Therapeutics) to treat men with certain forms of hypogonadism, the agency announced in a press release. The approval marks the first new oral testosterone replacement product in more than 60 years.
FDA approves marketing of generic testosterone gel
The FDA approved marketing of a generic version of testosterone gel 1.62% as replacement therapy for men with hypogonadism, according to a press release from Lupin.