novo nordisk semaglutide pill launches its Wegovy weight-loss drug to the US market, GoodRx discounts it Novo Nordisk launches Wegovy subscription

At the highest dose (equivalent to FDA-approved 17.2mg), participants who stayed on treatment for the full 72 weeks lost an average of 12.4% (~27 lbs)

Regulatory History Empowers enforcement record spans nearly a decade across both its 503A and 503B operations: 2017 FDA Warning Letter issued after a 2015 inspection found that Empower produced drug products without valid prescriptions for individually identified patients, and that sterile drug products were prepared under insanitary conditions that put patients at risk 2021 FDA Warning Letter issued to the 503B outsourcing facility after a 2020 inspection found that drug products failed to meet the conditions of Section 503B of the FDCA 2024 FDA Form 483 documented fill weight discrepancies in semaglutide vials, inadequate quality control sampling procedures, and deficiencies in aseptic processing areas April 2025 FDA Warning Letter cited drug products intended or expected to be sterile that were prepared, packed, or held under insanitary conditions

doi: 10.2337/dc12-1925

The STEP 1 trial extension (semaglutide 2.4 mg) showed participants regained two-thirds of lost weight within one year of stopping

Singh G, Krauthamer M, Bjalme-Evans M