Generic to Oxistat Approved
March 11, 2016 – The U.S. Food and Drug Administration announced its approval of Taro Pharmaceutical’s Oxiconazole cream 1% for the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) and tinea versicolor (generalized rash or discolored patches), that are caused by specific types of fungus. Oxiconazole cream 1% is the first generic alternative to Fougera Pharmaceutical’s Oxistat, a topical antifungal drug, applied to affected areas once or twice a day. It is advised that patients or caregivers wash their hands thoroughly after applying oxiconazole to prevent its touching the eyes or the mucous membranes. It is also recommended that patients be evaluated for improvement in the infected area after 2 to 4 weeks of treatment. There is currently no information on plans for pricing or information.
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.