The FDA has approved Liletta, an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy for up to 3 years. The fourth IUD to be approved in the US, and the third that releases levonorgestrel, Liletta is comarketed by Actavis and Medicines360, a nonprofit women's health pharmaceutical company. The wholesale cost of Liletta is similar to that of other IUDs (see Table 1), but the manufacturer offers programs that significantly reduce the cost for commercially-insured patients and clinics serving low-income women.

The FDA has approved daclatasvir (Daklinza – BMS), an oral direct-acting antiviral drug, for use with sofosbuvir (Sovaldi) for treatment of chronic hepatitis C virus (HCV) genotype 3 infection. Daclatasvir is the first drug approved for this indication that does not require the addition of interferon or ribavirin. It is approved in Japan and Europe in combination with other drugs for treatment of HCV genotypes 1-4.

The FDA has approved Bexsero (Novartis/GSK), a vaccine that protects against invasive meningococcal disease caused by Neisseria meningitidis serogroup B. It is the second serogroup B meningococcal vaccine to be approved in the US; Trumenba was the first. Both vaccines are approved for use in persons 10-25 years old. Bexsero is approved in Europe, Canada, and Australia for use in children as young as 2 months old.

The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.

The FDA has approved a fixed-dose combination of lumacaftor and ivacaftor (Orkambi – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥12 years old who are homozygous for the F508del mutation. About 50% of patients in the US with CF are homozygous for the F508del (also called Phe508del) mutation. This is the first approved indication for lumacaftor; ivacaftor is available alone as Kalydeco for treatment of CF in patients ≥2 years old with other mutations. Orkambi is the first drug to be approved in the US for treatment of patients with the F508del...

The FDA has approved Inbrija (Acorda), an orally inhaled dry-powder formulation of levodopa, for intermittent treatment of "off" episodes in patients with Parkinson's disease (PD) being treated with carbidopa/levodopa (Sinemet, and others).

The FDA has approved the dual endothelin receptor antagonist aprocitentan (Tryvio – Idorsia) for use in combination with other antihypertensive drugs to treat hypertension in adults whose blood pressure is not adequately controlled on other drugs. Three other dual endothelin receptor antagonists, ambrisentan (Volibris, and generics), bosentan (Tracleer, and generics), and macitentan (Opsumit), are available in the US for treatment of pulmonary arterial hypertension.

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....

FluMist (AstraZeneca), the live-attenuated intranasal influenza vaccine that has been available for years for administration by a healthcare provider in nonpregnant persons 2-49 years old, has now been approved by the FDA for self- or caregiver-administration. It is expected to be available for such use during the 2025-2026 influenza season. FluMist is only available through a healthcare provider this season. It will continue to be available for administration by a healthcare provider in the future

The FDA has approved deutetrabenazine (Austedo – Teva), a vesicular monoamine transporter 2 (VMAT2) inhibitor, for treatment of chorea associated with Huntington's disease and, more recently, for treatment of tardive dyskinesia in adults. It is the second VMAT2 inhibitor to be approved for each of these indications; tetrabenazine (Xenazine, and generics) was approved earlier for Huntington's chorea and valbenazine (Ingrezza) was recently approved for treatment of adults with tardive dyskinesia.