FDA approves Hikma's generic version of Novo Nordisk A/S Sponsored ADR Class B (NVO.US) diabetes drug Victoza.

The U.S. Food and Drug Administration (FDA) approved Hikma's generic version of Novo Nordisk A/S Sponsored ADR Class B (NVO.US) diabetes drug Victoza on Monday, clearing the way for another generic version of the drug to hit the market in the United States. Hikma's branded generic will compete with Teva Pharmaceutical Industries, who earlier this year launched an authorized generic version of Victoza in the U.S. Authorized generics are exact replicas of brand-name drugs, sold by another company under license from the brand-name drug manufacturer. Hikma's branded generic, like other generic versions, may contain some minor differences. Iilun Murphy, director of the FDA's Office of Generic Drugs, said, "Generic drugs offer additional treatment options, often at a more affordable price for patients." Hikma said on Monday, "We are delighted to receive FDA approval to launch this important medicine and provide wider access and greater affordability to patients who rely on it." The company expects the drug to be available nationwide by the end of this year. The drug was temporarily approved by the FDA in June. The diabetes drug Victoza is a first-generation GLP-1, a class of treatment that has seen overwhelming demand. It has been on the FDA's shortage list since 2023 and is still in short supply. The agency said it prioritizes reviewing generic drugs in shortage. The brand-name Victoza is currently in high demand. The authorized generic version of Victoza produced by Teva is not in shortage. Victoza is a once-daily injectable approved for adults with type 2 diabetes and children aged 10 and older. With the loss of patent protection last year and patients shifting towards more effective and once-weekly treatments such as Ozempic from Novo Nordisk A/S Sponsored ADR Class B and Mounjaro from Eli Lilly, demand for the drug has been declining.