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Posted On: 06/05/2025 8:08:22 AM
Post# of 154604
Pardon my potential ignorance, but how could a licensee "mothball a LL indication"?
Once a drug is approved by the FDA for at least one use, healthcare providers can use their medical judgment to prescribe it for other medically appropriate purposes, even if those uses are not on the approved labeling.
Off-label prescribing is a common practice in medicine, with some estimates suggesting that 1 in 5 prescriptions written are for off-label uses. Of course CYDY (or the licensee) could not tout LL for an indication that it was not approved for.
Sure, maybe some insurance companies won't pay for it off-label, but that won't mean that people cannot get it some way.
Once a drug is approved by the FDA for at least one use, healthcare providers can use their medical judgment to prescribe it for other medically appropriate purposes, even if those uses are not on the approved labeling.
Off-label prescribing is a common practice in medicine, with some estimates suggesting that 1 in 5 prescriptions written are for off-label uses. Of course CYDY (or the licensee) could not tout LL for an indication that it was not approved for.
Sure, maybe some insurance companies won't pay for it off-label, but that won't mean that people cannot get it some way.
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