Lucentis Receives Fourth U.S. Approval
The U.S. Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) 0.3mg to extend its indication to include the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The recommended dose is 0.3mg (0.05mL) of Lucentis injected into the affected eye(s) once a month by a healthcare professional trained in its use. It is recommended to be used along with diet and other medications that manage blood pressure, blood sugar and cholesterol levels.
Lucentis was originally FDA-approved in 2006 for treating general DME and subsequently approved for the treatment of wet age-related macular degeneration (AMD) and macular degeneration due to obstructed retinal veins. In the United States, Lucentis is sold by Genentech, a member of the Roche Group.
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.