Osteoarthritis Therapy Vivlodex Approved
October 22, 2015 – The U.S. Food and Drug Administration approved Vivlodex (meloxicam) manufactured by Iroko Pharmaceutical, for the treatment of osteoarthritis pain. Vivlodex is a non-steroidal anti-inflammatory drug (NSAID), with a low-dose formulation consisting of very small drug particles in a patented base that dissolves faster than previously available dose forms of meloxicam. Vivlodex is recommended to be taken once daily. Dosage forms available are 5mg and 10mg capsules and are not directly interchangeable with other meloxicam products currently on the U.S. market. NSAIDs such as Vivlodex are advised to be taken only long enough for pain to resolve, since the use of them have been associated with increased risks of gastrointestinal (GI) damage, heart attacks, and strokes.
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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.