05:47 PM EDT, 09/17/2024 (MT Newswires) -- Theratechnologies ( THTX ) said late Tuesday that there is a risk of temporary supply disruption for Egrifta SV injection in early 2025 due to an unexpected voluntary shutdown of its contract manufacturer's facility following an inspection by the US Food and Drug Administration.
Egrifta SV is a medication for the reduction of excess abdominal fat in HIV-infected adult patients.
The company said it will manage inventory levels to meet patient demand until January and these measures will cause a shortfall of $1.6 million in Egrifta SV during fiscal 2024.
To resume the drug's distribution, Theratechnologies ( THTX ) said it will need to file a prior approval supplement detailing the changes made by its manufacturer. The company expects to file the PAS around the manufacturing date and the FDA will review it within four months of receipt.
Shares of the company fell 2.9% in recent after-hours activity.
Price: 1.3300, Change: -0.04, Percent Change: -2.92