The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
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The Company expects to start Phase 3 studies for ATTR cardiomyopathy and polyneuropathy in the first half of 2019.
Esmolol Hydrochloride in Sodium Chloride Injection 2500mg/250 mL (10mg/mL) Single-Dose Plastic Bag and 2000mg/100mL (20mg/mL) Single-Dose Plastic Bag, a generic version of Brevibloc (Baxter) now available from Mylan.
The Company is currently enrolling patients in a randomized, double-blind, placebo-controlled Phase 2 trial; they expect to enroll 175 in total.
The risk of angioedema is likely comparable between aliskiren and beta blockers.