Theratechnologies announced on Thursday that a shortage of Egrifta SV, its prescription medication designed to decrease excess abdominal fat in adults living with HIV and lipodystrophy, is expected to occur in mid-January.
The Canadian biopharmaceutical firm linked the supply shortage to a voluntary closure of the drug's contract-manufacturing plant that occurred last year.
The company mentioned that it currently has two newly-produced batches of Egrifta SV ready for distribution to pharmacies. However, it is still waiting for feedback from the Food and Drug Administration concerning a prior approval supplement that was submitted in December.
A prior approval supplement is a formal request submitted to the FDA seeking authorization for significant modifications to a drug or biological product. This approval must be obtained before the changes can be executed and the product can be made available to consumers.
"We are dedicated to supporting individuals living with HIV who depend on Egrifta SV, the sole FDA-approved treatment of its type," stated Chief Medical Officer Christian Marsolais. "Our efforts will persist in collaboration with the FDA to accelerate the availability of new batches for our patients."
Write to Connor Hart at [email protected]
(END) Dow Jones News Services
January 9, 2025, 5:49 PM ET (10:49 PM GMT)
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