Lomaira Approved for Weight Loss
September 12, 2016 – The US FDA approved Lomaira™ (phentermine) tablets, 8mg, manufactured by KVK-Tech, Inc. Lomaira is indicated to be used only for a few weeks by patients 18 years of age and older who need to lose weight. Behavior modification, calorie restriction and exercise are recommended along with its use. It is intended for patients who have a body mass index (BMI) in the obese range (30kg/m2 or above) and for overweight patients (BMI between 27kg/m2 and 30kg/m2) who have additional risk factors, such as diabetes and high cholesterol. The recommended dose is one tablet three times a day, one-half hour before each meal.
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 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.