Daklinza Approved for Hepatitis C Virus (HCV) Genotype 3
July 24, 2015 – The U.S. Food and Drug Administration (FDA) approved Daklinza (daclatasvir) for the treatment of patients with Hepatitis C Virus (HCV) genotype 3 infection. Daklinza, manufactured by Bristol Myers Squibb, is to be used in combination with Sovaldi (sofosbuvir). The recommended dose for Daklinza is one 60mg tablet with one 400mg tablet of Sovaldi, once daily for 12 weeks and is anticipated to carry a list price of $63,000 for the 12-week regimen, just for the Daklinza.
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.