Generic Launched for Voltaren Gel
March 18, 2016 – The U.S. Food and Drug Administration granted approval to Amneal Pharmaceutical’s Didofenac gel 1%; a topical non-steroidal anti-inflammatory drug (NSAID) for the treatment of Osteoarthritis in affected joints. Didofenac gel is the first generic for Endo Pharmaceutical’s Voltaren gel. The gel will be dispensed in cards that measure doses into 2 or 4 gram units. The 2 gram units will be used for fingers, hands, wrist, and elbow joints, while the 4 gram units will be used for foot, ankle, and knee joints. The recommended dosage for use is four times a day with a total daily dosage of no more than 32 grams. Like all NSAIDs, the boxed label for Diclofenac gel includes a warning that using it may raise the risk of heart attacks, strokes, and gastrointestinal; (GI) problems, such as stomach bleeding and ulcers. Diclofenac gel is available in 100 gram tubes. According to IMS Health, the estimated sales in the U.S.A for Voltaren gel for the 12-month period that ended on January 31st 2016 is $413 million.
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.