Amgen files label update for Tavneos as FDA intensifies withdrawal push

Amgen has submitted a supplemental filing to the FDA to revise the prescribing information for its osteoporosis drug Tavneos.

The amendment adds expanded safety warnings as the agency escalates its efforts to withdraw the product from the market, reflecting an ongoing dispute between the company and regulators.

The move underscores heightened scrutiny of Tavneos and could affect its availability pending further FDA review.