Friday, May 3, 2019

FDA on endocrine drugs



  • The FDA has approved the monoclonal antibody romosozumab to treat osteoporosis in postmenopausal women at high risk for fracture
  • The FDA issued a complete response letter declining to approve a new drug application for oral sotagliflozin a first-in-class dual SGLT1 and SGLT2 inhibitor for adult with type 1 diabetes
  • FDA approved an oral hydrogel therapy that induces feelings of fullness without adding calories for adults with overweight and obesity
  • FDA issued a safety labeling change order to Sprout Pharmaceuticals for the serotonin receptor agonist flibanserin ordering a modification to the boxed warning that states alcohol use is contraindicated when taking the drug.
  • FDA approved testosterone undecanoate in an oral capsule 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.
·                     The FDA approved marketing of a generic version of testosterone gel 1.62% as replacement therapy for men with hypogonadism.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

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