Ozempic Injection Approved for Type 2 Diabetes
December 5, 2017 – The U.S. FDA has approved Ozempic® (semaglutide) injection, manufactured by Novo Nordisk, to improve glycemic control in adults who have type 2 diabetes. Ozempic should be used in conjunction with diet and exercise, and may help patients lose weight.
A long-acting glucagon-like peptide-1 (GLP-1) agonist, Ozempic is taken once per week as a self-administered subcutaneous (SC) injection. Its recommended starting dose is 0.25mg weekly for the first four weeks, with an increase to 0.5mg per week afterward for maintenance. If necessary, dosage can be increased to 1mg per week to provide additional glycemic control. Ozempic works by slowing glucose absorption after meals, promoting the secretion of insulin from the pancreas, and decreasing glucagon production.
A number of other GLP-1 agonists are currently available in the United States, all of them delivered via self-administered SC injection, and most taken once per week. Ozempic is expected to launch during the first quarter of 2018, and will be available in a carton containing one pen able to deliver eight 0.25mg doses or four 0.5mg doses, as well as a carton containing two pens that deliver four 1mg doses each. Novo Nordisk has announced that it expects to price Ozempic at $676 per prescription.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.