Harvoni (ledipasvir/sofosbuvir) tablet
Olysio (simeprevir) capsule
Sovaldi (sofosbuvir) tablet
“Warning and Precautions,” “Adverse Reactions,” and “Drug Interactions” sections of the labeling and the patient package insert were updated to include information on the occurrence of serious symptomatic bradycardia when the antiarrhythmic drug amiodarone is taken with hepatitis C treatments containing ledipasvir/sofosbuvir (Harvoni) or with sofosbuvir (Sovaldi) taken in combination with another direct-acting antiviral.
The Boxed Warning, Indications for Usage, Dosage and Administration, and Warnings and Precautions sections of lomitapide mesylate product labeling were updated in May 2016.
The Warnings and Precautions section of lomitapide mesylate product labeling was updated in May 2016 to include the risk of severe diarrhea.
The “Warnings and Precautions” and “Contraindications” sections of the labeling were updated to include anaphylaxis.
The “Dosage and Administration” section of the labeling was updated to include information that the delayed-release tablet and oral suspension are not interchangeable due to the differences in the dosing of each formulation. Also, the outer carton/container now includes an “attention” statement.
The “Warnings and Precautions” section of the labeling was updated to include hepatotoxicity.
Starting in April 2013, the battery pack was redesigned and included on all new nebulizers.
Previously distributed nebulizers were replaced by the new battery pack. By June 2015, all U.S. Tyvaso patients should have transitioned to the new battery pack.
The sponsor reports no complaints of thermal events with the new battery pack.
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"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.
Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.
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