FDA keeps Ozempic 2 mg/1.5 mL on the generic approval track
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA says Ozempic semaglutide solution, 2 mg/1.5 mL, was not pulled from sale for safety or effectiveness reasons. That keeps the product eligible to stay in the Orange Book’s discontinued list and allows generic drug applications that refer to it to move forward if they meet the normal legal and scientific standards. For Novo Nordisk, generic drug makers, and regulators, the practical effect is clear: FDA will not start the process to remove approval pathways tied to this product. Companies developing generic versions can continue work, and if FDA later requires updated labeling, applicants may have to revise it before approval.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- FDA determined Ozempic 2 mg/1.5 mL was not withdrawn for safety or effectiveness reasons
- The product remains listed in the Orange Book's Discontinued Drug Product List
- ANDA applications referring to this product may continue to be approved if they meet all other requirements
Obligations
What this law requires
FDA must continue to list OZEMPIC (semaglutide) solution, 2 mg/1.5 mL, in the Orange Book’s Discontinued Drug Product List because it was determined not to have been withdrawn from sale for reasons of safety or effectiveness.
FDA must continue to list OZEMPIC (semaglutide) solution, 2 mg/1.5 mL, in the Orange Book's Discontinued Drug Product List because it determined the product was not withdrawn from sale for reasons of safety or effectiveness.
FDA may approve ANDAs that refer to OZEMPIC (semaglutide) solution, 2 mg/1.5 mL, only if the applications satisfy all applicable legal and regulatory requirements, including sameness and bioequivalence requirements under section 505(j).
FDA may continue to approve ANDAs that refer to OZEMPIC (semaglutide) solution, 2 mg/1.5 mL, provided the applications meet all other applicable legal and regulatory requirements for ANDA approval.
ANDA applicants referencing OZEMPIC (semaglutide) solution, 2 mg/1.5 mL, must satisfy the usual ANDA requirements, including sameness of active ingredient, dosage form, route of administration, strength, conditions of use, and bioequivalence to the listed drug.