View the Expanded Table: Some Drugs for Altitude Illness, Jet Lag, and Motion Sickness

The FDA has approved Qmiiz ODT (TerSera), an orally disintegrating tablet formulation of the prescription NSAID meloxicam. Qmiiz ODT, like conventional oral meloxicam tablets (Mobic, and generics), is indicated for relief of the symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults and of juvenile RA in children who weigh ≥60 kg. Vivlodex, a low-dose capsule formulation of meloxicam, is FDA-approved only for management of OA pain.

The FDA has approved glucagon nasal powder (Baqsimi – Lilly) for treatment of severe hypoglycemia in patients ≥4 years old with diabetes. Baqsimi is the first noninjectable glucagon formulation to become available in the US. Injectable glucagon emergency kits (GlucaGen Hypokit, and generic) have been available for years, but they require reconstitution of the lyophilized powder by the caregiver immediately before injection. An injectable glucagon formulation that does not require reconstitution was recently approved by the FDA (Gvoke) and is expected to become available...

Lefamulin (Xenleta – Nabriva), a semisynthetic pleuromutilin antibiotic, has been approved by the FDA for IV and oral treatment of community-acquired bacterial pneumonia (CABP) in adults. It is the first systemic pleuromutilin antibiotic to be approved in the US; retapamulin (Altabax), a 1% topical ointment for treatment of impetigo, was approved in 2007.

The FDA has approved Duaklir Pressair (Circassia), a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and the longacting beta₂-adrenergic agonist (LABA) formoterol fumarate, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Aclidinium/formoterol is the fifth LAMA/LABA combination to be approved in the US for this indication.

The lipid-lowering drug rosuvastatin is now available in a sprinkle capsule formulation (Ezallor Sprinkle – Sun Pharma). Rosuvastatin tablets (Crestor, and generics) have been available since 2003.1,2The new formulation is being marketed specifically for residents of long-term care facilities who have difficulty swallowing. Ezallor Sprinkle capsules can be swallowed whole or opened and their contents sprinkled over applesauce or mixed with water for administration via nasogastric tube.For those long-term care residents who still have a reasonable indication for a statin but have difficulty...

View the Expanded Table: Statins

The FDA has approved solriamfetol (Sunosi – Jazz), a dopamine and norepinephrine reuptake inhibitor (DNRI), to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). Pitolisant (Wakix), an H3-receptor antagonist/inverse agonist recently approved by the FDA for treatment of excessive daytime sleepiness in patients with narcolepsy, will be reviewed in a future issue.

On August 6, 2019, the FDA issued a statement on data manipulation/inaccuracy issues with Zolgensma, a virus vector-based gene therapy approved for one-time IV treatment of children <2 years old with spinal muscular atrophy.1 We reviewed Zolgensma in our July 29 issue.2 According to the FDA statement, the manipulated data pertained to the production process for the product and did not affect the efficacy or safety results from the human clinical trials. It does not require any change in our review.FDA Statement. Statement on data accuracy issues with recently approved gene therapy....

The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, and generics), as a once-daily complete regimen for treatment of adults with HIV-1 infection who are antiretroviral-treatment naive and have no known substitutions associated with resistance to either drug. Dolutegravir/lamivudine is the first complete regimen to be approved by the FDA for initial treatment of HIV-1 infection that contains 2 rather than 3 antiretroviral...