By Connor Hart
Theratechnologies said Thursday that patients will encounter a shortage of Egrifta SV--its prescription medicine that reduces excess belly fat in adults with HIV and lipodystrophy--in mid-January.
The Canadian biopharmaceutical company attributed the shortage to a voluntary shutdown of the drug's contract-manufacturing facility last year.
It added that it has two recently-manufactured batches of Egrifta SV waiting to be released to pharmacies. The company, however, is awaiting a response from the Food and Drug Administration regarding a prior approval supplement it submitted in December.
A prior approval supplement is a request to the FDA for approval to make a major change to a drug or biological product, and it is required before the change can be implemented and the drug can be distributed.
"We remain committed to people with HIV who rely on Egrifta SV, as it is the only FDA-approved medicine of its kind," Chief Medical Officer Christian Marsolais said. "We will continue to work with the FDA to expedite the release of the new batches for patients."
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
January 09, 2025 17:34 ET (22:34 GMT)
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