America Meals and Drug Management on Monday authorized Hikma Prescription drugs’ generic model of Novo Nordisk’s diabetes drug, Victoza, clearing the best way for the release of any other replica of the remedy within the nation.
Hikma’s branded generic will compete with Teva Prescription drugs licensed generic of Victoza in the US that used to be introduced previous this 12 months.
Approved generics are the precise copies of branded medication, bought via any other corporate with the branded drug producer’s permission.
America Meals and Drug Management on Monday authorized the generic model of Novo Nordisk’s diabetes drug. REUTERS
“Generic medication supply further remedy choices which might be typically extra reasonably priced for sufferers,” stated Iilun Murphy, FDA’s director of the Place of work of Generic Medicine.
Branded generics, reminiscent of Hikma’s, are copies of a branded drug that can include some minor variations.
“Generic medication supply further remedy choices which might be typically extra reasonably priced for sufferers,” stated Iilun Murphy, FDA’s director of the Place of work of Generic Medicine.
Hikma stated on Monday it used to be “happy to have FDA approval to release this vital medication and to supply broader get right of entry to and bigger affordability for the sufferers who depend on it”.
The corporate stated it expects the drug will likely be to be had national ahead of the top of the 12 months. The drug used to be tentatively authorized in June via the FDA.
Diabetes drug Victoza, or liraglutide, is a primary technology GLP-1, a category of remedies that has noticed overwhelming call for. It’s been at the FDA’s scarcity checklist since 2023, and lately stays in tight provide.
Medical type of the molecule semaglutide which is the energetic aspect in Novo Nordisk’s mega-blockbuster diabetes drug. REUTERS
The company stated it prioritizes overview of generic variations of gear which are in scarcity.
Victoza is a once-daily injection authorized to be used in adults and kids elderly 10 years or older with kind 2 diabetes.
Call for for the drug has been falling with the lack of patent coverage final 12 months and as sufferers transfer to more practical and once-weekly remedies reminiscent of Novo’s Ozempic and Eli Lilly’s (LLY.N), opens new tab Mounjaro.
