Generic for Frova Approved
March 13, 2016 – The U.S. Food and Drug Administration granted approval to Glenmark Pharmaceutical’s AB-rated generic to Elan’s Frova (frovatriptan) 2.5mg tablets. Frova is indicated for the treatment of migraine headaches, and to prevent menstruation-associated migraines. The recommended dose for Frova is one tablet to be taken at the beginning of the migraine pain, and if needed, a second tablet could be taken after two hours with no more than three tablets used in 24 hours. For menstruation-associated migraines, it is recommended that Frova be taken regularly for six days before the period starts. According to IMS Health, the approximate U.S. sales for Frova for the 12 months ending on January 31, 2016 were $88 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.