Revised labeling was issued for tadalafil (Cialis, Lilly ICOS), vardenafil (Levitra, Bayer/GlaxoSmithKline/Schering-Plough), and sildenafil (Viagra, Pfizer) to reflect a small number of post-marketing reports of sudden vision loss, attributed to non-arteritic ischemic optic neuropathy (NAION).
Revised labeling was issued for tadalafil (Cialis, Lilly ICOS), vardenafil (Levitra, Bayer/GlaxoSmithKline/Schering-Plough), and sildenafil (Viagra, Pfizer) to reflect a small number of post-marketing reports of sudden vision loss, attributed to non-arteritic ischemic optic neuropathy (NAION).
The labeling for efalizumab (Raptiva, Genentech/Xoma) was revised to include information about reports of immune-mediated hemolytic anemia and warnings regarding postmarketing reports of thrombocytopenia and serious infections including necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (eg, cellulitis, pneumonia) despite antimicrobial treatment.
FDA issued a public health advisory to alert health-care professionals, patients, and their caregivers of reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product (Duragesic, Janssen) and the generic product.
New labeling was issued for gefitinib (Iressa, AstraZeneca) that states the medication should be used only in cancer patients who have already taken gefitinib and whose doctors believe it is helping them.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
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FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
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FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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