Assertio is acutely aware that currently, this is an off-label use for the product and Assertio remains deeply committed to remaining compliance with FDA promotional regulations.

Source: https://seekingalpha.com/article/4585826-assertio-holdings-inc-asrt-q4-2022-earnings-call-transcript?source=feed_all_articles

But, there was off-label use for Ozempic as an anti-obesity medication too.

Source: https://biztoc.com/x/e4bd4bb1f7c37f44?ref=ff

Clinicians sometimes quietly prescribe pharmaceuticals or compounds like Melanotan for off-label conditions ahead of formal approvals.

Source: https://dodbuzz.com/powerful-effect-in-treating-erectile-dysfunction/

In addition, while doctors commonly prescribe drugs for uses not approved by the FDA — beta-blockers to lessen stage fright, for example, or the diabetes drug (semaglutide) for weight loss — the agency bans “off-label” promotion directly to consumers.

Source: https://worldcrunch.com/culture-society/regulation-telehealth

“I think in three to five years we’re going to start seeing things go what’s called off-label.

Source: https://globalnews.ca/news/9409950/therapeutic-psilocybin-access-canada-magic-mushrooms/

Rather, the insurer chose to fund a non-FDA-approved drug used by physicians off-label because it is cheaper.

Source: https://www.pressherald.com/2023/03/11/letter-to-the-editor-health-insurers-practices-warrant-investigation/

There are currently no licensed testosterone treatments for women in the UK, so NHS clinicians prescribe products licensed for men 'off-label' at lower doses considered suitable for women.

Source: https://www.dailymail.co.uk/health/article-11758669/Sex-boost-NHS-10-fold-spike-women-getting-testosterone-gel.html?ns_mchannel=rss&ns_campaign=1490&ito=1490

There have been ongoing global shortages of another injection for type 2 diabetes, called Ozempic, that some people have been buying off-label as a weight loss aid.

Source: https://www.bbc.co.uk/news/health-66022263?at_medium=RSS&at_campaign=KARANGA

The treatment is known as off-label drugs and not backed by the NHS.

Source: https://www.countypress.co.uk/news/23275887.isle-wight-father-battling-bowel-cancer-raises-tens-thousands/?ref=rss

We don't obviously see a whole lot of that kind of information, we don't anticipate very much off-label use.

Source: https://seekingalpha.com/article/4584146-ardelyx-inc-ardx-q4-2022-earnings-call-transcript?source=feed_all_articles

What we need in this country is a process for requiring manufacturers to seek F.D.A. approval where there are high rates of off-label use.

Source: https://www.nytimes.com/2023/03/05/opinion/letters/ketamine-teleheath.html