Most Recent Articles by Da Hee Han, PharmD
The FDA approval was supported by findings from a Phase 3, randomized, double-blind, placebo-controlled study that evaluated Imvexxy (4mcg and 10mcg) vs placebo from baseline to week 12.
A physician report indicates that 4 placebo (non-hormonal) capsules were placed in the first 4 days of therapy instead of active capsules.
The efficacy of Aimovig was evaluated as a preventive treatment of episodic or chronic migraine in 3 randomized, double-blind, placebo-controlled studies: 2 studies in patients with episodic migraine (4-14 migraine days per month) and 1 study in patients with chronic migraine (≥15 headache days per month with ≥8 migraine days per month).
The Agency has received reports of serious neural tube birth defects involving the brain, spine, and spinal cord in babies born to women who received dolutegravir for HIV treatment.
Benefits of protection with 2 doses administered over 1 month make the vaccine an important option for prevention of HBV.