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Off label indications often have some clinical significance to back the use, but they have not gone through the extensive testing required by the FDA to have an official labeled indication. Drug companies can not provide any official medication information (e.g. package inserts ) for off label indications.
Indications and Usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called " off-label uses ").
Prazosin (Minipress) for nightmares: prazosin is approved for the use of hypertension. A 2012 systematic review showed a small benefit for the treatment of PTSD-associated night terrors. Other non-FDA-approved uses for prazosin include the treatment of Raynaud's disease and poisoning due to scorpion venom.
The approval is the second indication for Zepbound, which was approved for weight loss for those with obesity, or who are overweight and have a weight-related health condition, in November 2023.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. [1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
The drug advertising regulation [38] contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug.
FDA Approves Expanded Indication for ACTEMRA ® in Rheumatoid Arthritis SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY ...
(Reuters) -The U.S Food and Drug Administration has approved the expanded use of Mirum Pharmaceuticals' oral drug to treat itching caused by a liver disorder in patients aged five years and older ...