September 1, 2020
- Kuvan tablets and powder (sapropterin dihydrochloride) – for phenylketonuria
Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.
- Submit a Report Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Send a Report Via U.S. Mail or Fax: Download a form from https://www.fda.gov/safety/reporting-serious-problems-fda/forms-reporting-fda or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the 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.