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https://www.fda.gov/media/185429/download
...or Proper Name Sofosbuvir (Sovaldi) Ledipasvir and sofosbuvir (Harvoni) Dosage...mg, 200 mg of sofosbuvir) • Pellets (200 mg, 150 mg of sofosbuvir) ...
https://www.fda.gov/media/169210/download
Names: Sovaldi (sofosbuvir), Harvoni (ledipasvir/sofosbuvir) Pediatric Labeling................. 2 1.1.1 Sovaldi (sofosbuvir) ...
https://www.fda.gov/media/134493/download
...them. • Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), first approved
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/october-december-2019-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
Epclusa (sofosbuvir and velpatasvir) Harvoni (ledipasvir and sofosbuvir) Vosevi...Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) Interaction with ...
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/april-june-2016-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event
...(daclatasvir) tablets Harvoni (ledipasvir and sofosbuvir) tablets Olysio (simeprevir)...(simeprevir) capsules Sovaldi (sofosbuvir) tablets Technivie ...
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/index-drug-specific-information
...(haloperidol) Haloperidol Harvoni (ledipasvir/sofosbuvir) Humira (adalimumab) Hydromorphone...Lazanda (fentanyl nasal spray) ledipasvir/sofosbuvir ...
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/january-march-2019-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
Epclusa (sofosbuvir and velpatasvir) tablet Harvoni (ledipasvir and sofosbuvir) tablet...and pibrentasvir) tablet Sovaldi (sofosbuvir) tablets ...
https://www.fda.gov/advisory-committees/pediatric-advisory-committee/pediatric-advisory-recommendations-and-updates
Review 09/19/2019 Harvoni (ledipasvir and sofosbuvir) Harvoni Pediatric Safety...Safety Review 09/19/2019 Sovaldi (sofosbuvir) Sovaldi Pediatric ...
https://www.fda.gov/media/182410/download
...gov/media/130828/download Harvoni ledipasvir/sofosbuvir 04/07/2017 9/23/19 https://www...gov/media/169208/download Harvoni ledipasvir/sofosbuvir ...
https://www.fda.gov/drugs/development-resources/reviews-pediatric-studies-conducted-under-bpca-and-pediatric-assessments-conducted-under-prea-2012
...(PDF - 10 MB) None None PREA Ledipasvir-sofosbuvir - Harvoni Gilead Sciences,...Statistical (PDF - 205 KB) PREA Ledipasvir-sofosbuvir - Harvoni Gilead ...
https://www.fda.gov/media/175364/download
...gov/media/169201/download Sovaldi sofosbuvir 4/7/2017 Meeting NA 9/23/19 https://www...gov/media/111506/download Epclusa sofosbuvir/velpatasvir ...
https://www.fda.gov/media/180157/download
...10/24/18 Jazz Cataplexy in narcolepsy Sofosbuvir 7/23/19 Gilead Chronic hepatitis...hepatitis C virus (HCV) infection Sofosbuvir/Ledipasvir 7/23/19 ...
https://www.fda.gov/drugs/development-resources/list-determinations-including-written-request
...145 KB] Amendment 2 [PDF - 92 KB] Sofosbuvir Gilead Sciences, Inc. 7/23/2019 Written...Amendment 3 [PDF - 253 KB] Sofosbuvir/Ledipasvir Gilead ...
https://www.fda.gov/media/164706/download
Interactions after Adding Simeprevir- or Sofosbuvir- containing therapy to Medication...upon addition of simeprevir- or sofosbuvir- containing ...
https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling
Patient Counseling Information Ledipasvir and Sofosbuvir Infectious Diseases IFNL3...Reactions, Clinical Pharmacology Sofosbuvir Infectious Diseases ...
https://www.fda.gov/media/169708/download
...gov/media/97522/download Sovaldi sofosbuvir 04/07/2017 Meeting NA Docket is Closed...gov/media/173318/download Epclusa sofosbuvir/velpatasvir ...
https://www.fda.gov/media/151045/download
...formulation support approval of sofosbuvir/velpatasvir (Epclusa®, SOF/VEL) for...study; and approval of SOF/VEL (sofosbuvir/velpatasvir, Epclusa®) for ...
https://www.fda.gov/news-events/press-announcements/fda-approves-two-hepatitis-c-drugs-pediatric-patients
...for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis...for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) ...
https://www.fda.gov/media/182650/download
Lasmiditan Eli Lilly and Company 10/19/18 Ledipasvir Gilead Sciences, Inc. 9/2/16 Leflunomide...oxybate Jazz Pharmaceuticals 3/10/14 Sofosbuvir Gilead ...
https://www.fda.gov/media/130830/download
Names: Sovaldi (sofosbuvir), Harvoni (ledipasvir/sofosbuvir) Pediatric Labeling................. 2 1.1.1 Sovaldi (sofosbuvir) ...