Withdrawal Notification: Rezvoglar® and Ravicti® (COM-2026-038)

PharmPix is committed to the health and wellness of our members. The clinical team wants to communicate the latest up-to-date drug withdrawal.

In September 2026, two manufacturers announced the market withdrawal of selected products, including Eli Lilly and Company's Rezvoglar®(insulin glargine-aglr) and Amgen's Ravicti® (glycerol phenylbutyrate).

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What are Rezvoglar (insulin glargine-aglr) and Ravicti (glycerol phenylbutyrate)?

Rezvoglar (insulin glargine-aglr) is a long-acting insulin and a biosimilar to Lantus® (insulin glargine). It is approved to improve glycemic control in adults and pediatric patients with diabetes mellitus and is administered once daily to help maintain blood glucose levels throughout the day.

Ravicti (glycerol phenylbutyrate) is a nitrogen-binding agent indicated for the chronic management of patients with urea cycle disorders (UCDs) who cannot be adequately managed with dietary protein restriction and/or amino acid supplementation alone. Ravicti is used in combination with a protein-restricted diet and, when appropriate, dietary supplements such as essential amino acids, arginine, citrulline, or protein-free calorie supplements to help control ammonia levels and reduce the risk of complications associated with UCDs.

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Market Withdrawal

In September 2026, Eli Lilly and Company announced the discontinuation of Rezvoglar (insulin glargine-aglr) as a business decision. The company stated that the product is not being withdrawn due to concerns related to safety or effectiveness. While manufacturing has been discontinued, distribution is expected to continue until existing inventory is depleted, with supply projected to remain available through June 2027.

Similarly, Amgen announced that it will discontinue Ravicti (glycerol phenylbutyrate) oral liquid effective December 31, 2026. After that date, the product will no longer be distributed by the manufacturer, however, existing inventory may continue to be available through pharmacies until supplies are depleted. Several FDA-approved generic versions of glycerol phenylbutyrate are currently available and may provide alternative treatment options for patients requiring continued therapy.

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Pharmacy Action

Identify affected patients and coordinate with prescribers on a transition plan before supply is exhausted.

For Rezvoglar, otherinsulin glargine products remain available. Confirm formulary status andcoverage before switching.

For Ravicti, FDA-approvedgeneric glycerol phenylbutyrate is available. Transitions should beprescriber-directed given the narrow management of urea cycle disorders.

Advise patients not to discontinue therapy on their own and to contact their provider with questions.

Additional information can be found at: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Insulin+Glargine-aglr+Injection&st=d&tab=tabs-4&panels=0

https://nucdf.org/resources/ucd-guides/generic-medications.html

Remember you can report adverse events related to this or any other drug product at MedWatch: The FDA Safety Information and Adverse Event Reporting Program by any of the following ways:

If you have any questions or wish to have more information regarding this document, you can call us at 787-522-5252-ext.219. Our pharmacists will help you.

In addition, know that you can access our recent communications at pharmpix.com/insights

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REFERENCES

1.      U.S. Food and Drug Administration. (n.d.). Insulin glargine-aglr injection drug shortage details. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Insulin+Glargine-aglr+Injection&st=d&tab=tabs-4&panels=0

2.     National Urea Cycle Disorders Foundation. (2026, September 15). RAVICTI® and genericglycerol phenylbutyrate updates. https://nucdf.org/resources/ucd-guides/generic-medications.html

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