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Pfizer Recalls Blood Pressure Drug Accuretic
The recall of Accuretic and generics distributed by Greenstone is a result of the presence of a cancer-causing agent.
Pfizer has recalled Accuretic (quinapril HCI/hydrochlorothiazide) tablets, as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) because of the presence of a nitrosamine, N-nitroso-quinapril, which can cause cancer.
Pfizer is recalling six lots of Accuretic, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets. Pfizer executives say they have not received any reports of adverse events related to this recall.
Accuretic and its generics are used to treat hypertension.
The lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from November 2019 to March 2022. A list of the lot numbers can be found here.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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Drugs to Watch: Mental Health Conditions
April 11th 2024The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
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