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The question stem describes that the drug is "newly marketed", so it's likely in Phase IV drug trials.
From FA 2019 pg. 256, Phase IV = "Postmarketing surveillance of patients after treatment is approved." Phase IV is for detecting rare side effects that weren't picked up during the smaller clinical trials or long-term effects. Phase IV determines if the drug can stay on the market.
The drug is approved and is appropriate to use in patients without side effects, but the drug is still being monitored by the FDA so any new, previously unreported side effects need to be filed with the FDA.