Contrave Approved for Weight Management
September 10, 2014 –The FDA approved Contrave (naltrexone HCI and bupropion HCI) extended-release tablets to be taken in addition to a reduced-calorie diet and exercise program for chronic weight management. Contrave is manufactured by Takeda and Orexigen.
Contrave is approved for use in adults considered to be obese who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. Initially Contrave is to be prescribed in a four-week dose escalation schedule followed by the recommended maintenance dose of two Contrave tablets taken twice daily. Patients should be evaluated after 12 weeks of the maintenance dosage. Launch is expected to be in Fall 2014. Contrave is anticipated to cost about $1,200 to $1,600 per year; however pricing information is not yet available.
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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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.