$Hims & Hers Health (HIMS.US)$ shares are 11% trading lower Thursday. The U.S. Food and Drug Administration issued a new decision about tirzepatide injection shortages. Here's what you need to know.
What To Know: The FDA announced today that the shortage of tirzepatide injections, a GLP-1 medication, has been resolved. The shortage began in 2022 due to high demand and has ended as manufacturing capacity and product availability are sufficient to meet national demand. However, the FDA warned of potential localized supply chain disruptions as products are distributed to pharmacies.
To avoid interruptions in treatment, the FDA is allowing compounders using tirzepatide to continue their activities temporarily. State-licensed pharmacies have until February 18, 2025, and outsourcing facilities until March 19, 2025, to comply with this grace period.
Meanwhile, other GLP-1 drugs, including dulaglutide, semaglutide and liraglutide, remain in shortage. Despite some reports of product availability, the FDA has not yet resolved these shortages and is actively monitoring the situation.
This announcement follows the FDA's October 2024 decision that determined that the tirzepatide shortage was over. However, this was reevaluated after legal challenges. This updated decision confirms that the shortage is resolved.
The news may influence investor sentiment, given the role of GLP-1 drugs in weight loss and diabetes treatment. Ongoing shortages of similar medications and regulatory updates could continue to affect market perspectives.