• 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