2012

• 06/26/2012 Incivek (telaprevir) product labeling revised
• 04/20/2012 Victrelis (boceprevir) label change reflects drug-drug interaction information with HIV protease inhibitors
• 03/01/2012 Important information about interactions between certains hepatitiC drugs and cholesterol-lowering statin drugs
• 02/09/2012 Victrelis (boceprevir) and Ritonavir-Boosted HIV Protease Inhibitor Drugs - Drug Interactions

2011

• 12/23/2011 Important updates to PegIntron labeling
• 12/20/2011 Intron A (Interferon alfa-2b) product labeling changes
• 11/29/2011 CLIA waiver expands availability of rapid blood test for antibodies to the hepatitis C Virus (HCV)
• 11/09/2011 Safe disposal of needles and other medical sharps
• 09/29/2011 Pegasys (peginterferon alfa-2a) new disposable autoinjector
• 08/23/2011 Pegasys and Copegus - pediatric indication for patients 5 -17 years of age
• 08/10/2011 Labeling change for Pegasys and Copegus re: dosing patients with renal impairment
• 06/06/2011 Labeling change for Intron A (Interferon alfa-2b) and PegIntron (Peginterferon alfa-2b)
• 05/25/2011 FDA briefing on boceprevir and telaprevir
• 05/23/2011 Approval of Incivek (telaprevir), a direct acting antiviral drug (DAA) to treat hepatitis C (HCV)
• 05/13/2011 Approval of VICTRELI (boceprevir) a direct acting antiviral drug (DAA) to treat hepatitis C virus (HCV)
• 04/26/2011 FDA Antiviral Advisory Committee April 28, 2011 meeting background materials available: telaprevir for Hepatitis C
• 04/25/2011 FDA Antiviral Advisory Committee April 27, 2011 meeting background materials available: boceprevir for Hepatitis C
• 04/07/2011 April 28, 2011 advisory committee meeting re: hep B testing in source plasma donations
• 04/01/2011 Labeling changes to Tyzeka (telbivudine) 600 mg tablets and oral solution 100 mg/5 mL reflect risk of resistance-associated substitutions
• 03/15/2011 FDA Advisory Committee meeting to consider boceprevir and telaprevir, April 27 and April 28, 2011
• 02/08/2011 Important information about alcohol prep pads packaged with Pegasys and certain other injection products
• 12/23/2011 Tyzeka (telbivudine) labeling updates re: use with pegylated interferon alfa-2a

2010

• 12/16/2010 New Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination
• 10/22/2010 New Baraclude (entecavir) tablets and oral solution dosing regimen for chronic Hepatitis B and decompensated liver disease
• 09/14/2010 Availability of draft Guidance: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment
• 07/06/2010 Infergen (interferon alfacon-1) label revision: combination therapy, weight-based dosing, and label format
• 06/28/2010 Rapid blood test for antibodies to the hepatitis C virus (HCV) approved
• 03/10/2010 Public Hearing and Request for Comments: Expanded Access to Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C Infection in Patients With Unmet Medical Need

2009

• 08/01/2012 Victrelis (boceprevir) label updated to reflect additional drug-drug interactions
• 09/01/2009 New class safety labeling updates for alpha interferon products
• 08/12/2009 New Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs
• Dose adjustments of PegIntron and Rebetol for certain patients with chronic hepatitis C
• Important information about Hydroxycut dietary supplement products
• Approval of new oral solution of Tyzeka for treatment of chronic hepatitis B (HBV)

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