FDA-approved drug
Reviewed for safety and efficacy for a specific use, made under manufacturing regulation.
What it means
The manufacturer submitted clinical trial evidence, the agency reviewed it, and the product is approved for named indications. Manufacturing is subject to inspection. The dose in the vial is the dose on the label, and adverse events are tracked systematically after approval.
Who oversees it
FDA pre-market review, ongoing manufacturing inspection, and post-market safety surveillance.
Questions worth asking
- Is this the brand-name product, dispensed by a licensed pharmacy?
- Am I being prescribed it for an approved indication, or off-label? If off-label, on what basis?
- What does it cost through the manufacturer's own direct-pay programme versus this seller?