Non-COVID-19 FDA news you may have missed in 2022
There was plenty of FDA news this year not related to COVID-19.
Below is a list of Healio stories published in 2022 about FDA approvals and authorizations not related to COVID-19.
FDA approves 2-month dosing of injectable, long-acting HIV treatment
Virologically suppressed adults can now receive HIV treatment as few as six times per year following the February FDA approval of a 2-month dosing regimen for Cabenuva — which includes shots of cabotegravir (ViiV Healthcare) and replevining (Janssen Pharmaceuticals) — for virologically suppressed adults on a stable regimen with no history of prior treatment failure or resistance to either drug. Read more.
FDA OKs first condom specifically indicated to prevent STIs during anal sex
In late February, the FDA authorized the marketing of One Male Condom, which the agency said is the first condom specifically indicated to help reduce the transmission of sexually transmitted infections during anal sex. Read more.
FDA makes oral lead-in optional for long-acting injectable HIV regimen
The FDA approved a label update for Cabenuva, making the oral lead-in period for the long-acting injectable HIV regimen optional, ViiV Healthcare announced in late March. Read more.
FDA approves long-acting injectable HIV regimen for adolescents
The FDA approved Cabenuva as the first long-acting HIV treatment regimen for virologically suppressed adolescents aged 12 years or older who weigh at least 35 kg, are on a stable ART regimen and have no history of treatment failure or resistance to either drug. Read more.
FDA approves 15-valent pneumococcal vaccine for children
Merck announced in late June that the FDA approved an expanded indication for Vaxneuvance, the company’s 15-valent pneumococcal conjugate vaccine, to include its use in infants and children aged 6 weeks to 17 years. Read more.
FDA approves flu medication Xofluza for younger children
The FDA approved the oral influenza medication Xofluza for children aged 5 to 11 years who have been symptomatic for no more than 48 hours, Genentech announced late this summer. Read more.
FDA authorizes Abbott’s monkeypox PCR test for emergency use
The FDA issued an emergency use authorization to Abbott Molecular for its real-time PCR test for monkeypox using lesion swab specimens from those with suspected virus infection, making it the first commercial test to be authorized for detection of monkeypox. Read more.
FDA approves second indication for ibrexafungerp in recurrent vulvovaginal candidiasis
The FDA approved ibrexafungerp, an oral, non-azole antifungal drug, for reducing the number of recurrent vulvovaginal candidiasis incidences, marking the second indication for ibrexafungerp, which was initially approved for the treatment of vulvovaginal candidiasis in June 2021. Read more.
FDA grants priority review for Pfizer’s RSV vaccine candidate for older adults
Earlier this month, the FDA granted priority review to a biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate, RSVpreF, for older adults. Read more.