- 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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