Expanded Teflaro Indication Approved
May 31, 2016 – The U.S. Food and Drug Administration (FDA) approved Teflaro® (ceftaroline fosamil), manufactured by Allergan. Teflaro is now indicated as a treatment for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) for patients aged 2 months to younger than 18 years. Teflaro is the only cephalosporin antibiotic with activity against methicillin-resistant Staphylococcus aureus (MRSA) in ABSSSI. In October 2010, Teflaro was first approved as a treatment for ABSSSI and CABP for adults.
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.