Ozempic, Wegovy Shortage Is Officially Over
Compounders given 60- to 90-day notice
https://www.medpagetoday.com/endocrinology/diabetes/114324
The shortage of semaglutide injections (Ozempic, Wegovy) is over, the FDA announced on Friday.
The agency, along with maker Novo Nordisk, confirmed that supply now meets or exceeds both the current and projected U.S. demand. The injectable formulation of the GLP-1 receptor agonist has been in shortage since August 2022 due to increased demand.
“Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies,” the FDA noted in a statement.
The shortage resolution applies to all strengths of semaglutide for type 2 diabetes, chronic weight management and major adverse cardiovascular event risk reduction.
The FDA said it will give compounders a grace period of 60 to 90 days to finish producing, distributing, and dispensing copies of semaglutide injection products to “avoid unnecessary disruption to patient treatment.”
Compounders are allowed to make copies of a drug only when it’s on the FDA shortage list, meaning the demand or projected demand of that drug exceeds the U.S. supply.
“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand,” said Dave Moore, executive vice president of U.S. operations and global business development and president of Novo Nordisk, in a statement
“No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients,” he added.
Two other GLP-1 receptor agonist products — dulaglutide (Trulicity) and liraglutide (Victoza, Saxenda) — still remain in shortage, the FDA noted.
Filed under: General Problems
Great. I wonder if they feel the same about severe adhd / auhd sufferers? What is happening with medication in that realm is criminal.
I believe you are experiencing is that during the COVID-19 crisis, the DEA granted virtual office visit for mental health. A couple of companies “jumped on” that exemption and started diagnosing a lot of pts with ADD & ADHD and prescribing meds to treat them. Their actions quickly depleted the limited pharma production quotas of those ADD/ADHD meds. Apparently the DEA has granted the pharmas some token increases in some ADD & ADHD meds
Yes, the DEA has raised production quotas for several ADHD medications in response to ongoing shortages14. Specifically:
The DEA increased the aggregate production quota (APQ) for lisdexamfetamine (Vyvanse) by approximately 24%15.
The APQ for dextroamphetamine, an active ingredient in Vyvanse and its generics, was raised by about 18%5.
The production quota for amphetamine, used in medications like Adderall, was increased by 5.9%3.
These increases were implemented to address rising demand and persistent shortages of ADHD medications4. However, it’s important to note that:
Despite the increases, some critics argue that the DEA’s quota system remains restrictive and may not fully resolve the supply issues6.
The FDA predicted a 3.5% increase in domestic medical use of Schedule II stimulants for 2025, indicating ongoing demand3.
Challenges in obtaining ADHD medications have persisted since October 2022, affecting various drugs including Adderall, Vyvanse, and Ritalin6.
While these quota increases represent a step towards addressing the shortages, their full impact on resolving the ongoing supply issues remains to be seen46.