FDA Updates

The FDA has granted emergency use authorization status for the first single-dose vaccine for COVID-19 in the United States.

Novartis’ sacubitril/valsartan (Entresto) is now indicated for use in the treatment of chronic heart failure.

Belantamab mafodotin-blmf is now indicated for adult patients with relapsed or refractory myeloma who have received at least 4 prior therapies.

Officials with the FDA have approved cabotegravir and rilpivirine, injectable formulation (Cabenuva; ViiV Healthcare) as a complete regimen for the treatment of HIV-1 infection in adults.

On October 22, 2020, the FDA approved remdesivir (Veklury; Gilead) as the first treatment for coronavirus disease 2019 (COVID-19).

The market for acute lymphocytic leukemia and bladder cancer drug therapies is expected to soar over the next few years, thanks in part to new and innovative medications.

Here are some of the top-read FDA approvals covered by Drug Topics® from this year.

Acetaminophen injection, 1000 mg/100 mL, is an FDA-approved generic to Ofirmev.

The FDA approved azacitidine tablets (Onureg; Celgene Corporation) on September 1, 2020

Tim Suther, senior vice president of data solutions at Change Healthcare, discusses a new Social Determinants of Health Analytics resource.

Lumasiran (Oxlumo; Alnylam Pharmaceuticals) is the first drug approved for the treatment of primary hyperoxaluria type 1, a rare genetic disorder.

SingleCare, in partnership with GeniusRx, launched the delivery service with the goal of improving access to and affordability of popular medications.

An overview of the use of satralizumab-mwge (Enspryng; Genentech) in neuromyelitis optica spectrum disorder (NMOSD).

Loteprednol etabonate ophthalmic suspension (Eysuvis; Kala Pharmaceuticals) 0.25% is the first ocular corticosteroid indicated for dry eye disease.

Remdesivir (Veklury; Gilead) is the first and only fully FDA-approved treatment for COVID-19.

Clascoterone cream 1% is a first-in-class topical acne treatment that targets the androgen receptors in the skin.

Oliceridine (Olinvyk; Trevena, Inc) is an intravenous opioid agonist indicated in adults for management of acute severe pain in a hospital or controlled clinical setting.

Apomorphine hydrochloride (Kynmobi; Sunovion) is a sublingual therapy for the acute intermittent treatment of off episodes in patients with Parkinson disease.

On June 25, 2020, fenfluramine (Fintepla) was approved for the treatment of seizures associated with Dravet syndrome in patients 2 years and older.

The FDA has approved OTC ketotifen fumarate (Alaway Preservative Free; Bausch + Lomb and Eton Pharmaceuticals) ophthalmic solution, 0.035% antihistamine eye drops.

Teva’s 2 digital inhalers for patients with asthma provide insight into objective inhaler use data.

Fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta; GlaxoSmithKline) is indicated for the treatment of asthma in patients aged 18 years and older.

Tramadol hydrochloride (Qdolo; Athena Bioscience) oral solution is indicated for use when pain is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Oral azacitidine (Onureg; Celgene) is approved for patients in first remission with acute myeloid leukeimia.

Here's the coronavirus-related news from this week that you should know.

Abbott’s BinaxNOW COVID-19 Ag Card rapid test produces results in 15 minutes.

Amisuplride injection (Barhemsys; Acacia) is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed prior prophylaxis with an agent of a different class.

Mylan has launched the first FDA-approved generic version of Biogen’s dimethyl fumarate (Tecfidera) for relapsing forms of multiple sclerosis.