Emflaza Approved For Duchenne Muscular Dystrophy
February 9, 2017 – The U.S. FDA approved Emflaza™ (deflazacort), manufactured by Marathon Pharmaceuticals. It is indicated to treat patients with Duchenne muscular dystrophy (DMD) who are five years of age and older. Emflaza is an oral corticosteroid that decreases both immune and inflammatory activity to relieve symptoms of DMD and also to delay progression of the disease. Emflaza will be available in 6mg, 18mg, 30mg and 36mg oral tablets and 22.75mg/mL oral suspension. The recommended dose is 0.9mg/kg once daily. Emflaza is expected to be launched in four to six weeks. It will be available through a limited network of specialty pharmacies.
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.