FDA made many decisions impacting Americans’ health in 2021
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As of Dec. 1, the FDA had approved 46 novel drugs this year, one fewer than it had approved by the same date in 2020.
One novel drug approval in 2021 was Aduhelm, the first treatment for Alzheimer’s disease since 2003. Regarding COVID-19, the FDA authorized several monoclonal antibody cocktails and several boosters for specific cohorts and approved the Pfizer-BioNTech vaccine for certain populations with COVID-19 in 2021.
Other treatments such as Nucala for chronic rhinosinusitis with nasal polyps, Trudhesa for adult migraine and a higher dose naloxone hydrochloride nasal spray for opioid overdose. also received the FDA's approval, and the agency announced several new initiatives, including one to curve foodborne illness.
Below, find additional highlights of Healio’s FDA coverage in 2021.
FDA approves Twyneo cream for acne vulgaris
Twyneo cream, a fixed-dose combination of tretinoin and benzoyl peroxide, has been approved by the FDA for the treatment of acne vulgaris, Sol-Gel Technologies announced in a press release. Read more.
FDA requests removal of strongest warning against using statins during pregnancy
The FDA requested that manufacturers of statins remove its strongest warning from current prescribing information, which states that these medications should never be used during pregnancy. Read more.
FDA approves Zeposia for moderate-to-severe ulcerative colitis
The FDA approved Zeposia 0.92 mg for the treatment of moderate-to-severe ulcerative colitis. Read more.
FDA approves Kerendia for the treatment of CKD, type 2 diabetes
The FDA approved Kerendia for reducing the risk for kidney and heart complications among adults with chronic kidney disease associated with type 2 diabetes. Read more.
FDA approves novel oral contraceptive pill
The FDA approved a combination drospirenone and estetrol tablet for the prevention of pregnancy, the first combination pill containing naturally occurring estrogen, according to an industry press release. Read more.
FDA commits to advancing ban on menthol in cigarettes, flavored cigars
The FDA announced it is working toward issuing product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all flavors, including menthol. Read more.
FDA approves first long-acting injectable regimen for HIV
The FDA approved the first long-acting injectable regimen for HIV treatment, Cabenuva, which includes shots of cabotegravir and rilpivirine given just once a month. Read more.
FDA OKs remote electrical neuromodulation device in children with migraine
The FDA expanded the approval of a remote electrical neuromodulation device to treat episodic and chronic migraine in children aged 12 years and older, according to a press release issued by the manufacturer. Read more.
Baxter receives FDA clearance for ‘artificial kidney’ dialysis machine
The FDA granted 510(k) clearance to Baxter for its portable hemodialysis machine, titled Artificial Kidney 98. The machine is already used in 90 countries, according to a press release. Read more.
FDA issues new guidance on sodium, calls it ‘pivotal’ moment in US health
The FDA issued voluntary guidelines that are intended to lower excess sodium intake from packaged, processed and prepared foods, the agency said. Read more.
Tyrvaya nasal spray receives FDA approval for treatment of dry eye disease
The FDA approved Tyrvaya nasal spray for the treatment of signs and symptoms of dry eye disease, according to a press release from Oyster Point Pharma. Read more.
FDA approves opioid overdose antidote Zimhi
The FDA approved Zimhi, a high-dose naloxone product that is administered through a prefilled syringe to counteract potentially fatal opioid overdoses, the agency and the drug’s manufacturer announced. Read more.
FDA, FTC issue warnings for dietary supplements claiming to treat diabetes
The FDA and the Federal Trade Commission issued warning letters to 10 companies that market unapproved supplements to treat diabetes and urged consumers not to use the products, which may be harmful. Read more.
FDA approves Cortrophin Gel for rheumatoid arthritis, multiple sclerosis
The FDA approved a supplemental new drug application for ANI Pharmaceutical’s Cortrophin Gel to treat rheumatoid arthritis, multiple sclerosis and certain other autoimmune diseases, according to a company press release. Read more.
FDA grants 510(k) clearance for vagus nerve stimulation device in adolescent migraine
The FDA granted 510(k) clearance to electroCore to expand the approval of gammaCore, the company’s non-invasive vagus nerve stimulation, for the acute and preventative treatment of adolescent migraine, according to a press release. Read more.
References
Novel drug approvals for 2020. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020. Last updated Jan. 13, 2021. Accessed Dec. 16, 2021.
Novel drug approvals for 2021. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021. Last updated Nov. 30, 2021. Accessed Dec. 16, 2021.