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Daklinza FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 25, 2019.

FDA Approved: Yes (Discontinued) (First approved July 24, 2015)
Brand name: Daklinza
Generic name: daclatasvir
Dosage form: Tablets
Company: Bristol-Myers Squibb Company
Treatment for: Hepatitis C

Marketing Status: Discontinued

Daklinza (daclatasvir) is an NS5A inhibitor indicated for use in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.

Development timeline for Daklinza

Feb  5, 2016Approval FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C
Jul 24, 2015Approval FDA Approves Daklinza (daclatasvir) for Chronic Hepatitis C Genotype 3 Infections
Mar 12, 2015BMS Announces Acceptance of NDA for Daclatasvir for FDA Review for Hepatitis C Genotype 3
Apr  7, 2014Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C

Further information

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