Xarelto is approved to treat and prevent blood clots in pediatric patients
The FDA approved two new pediatric indications for Xarelto (rivaroxaban): the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years of age who have received at least 5 days of initial parenteral anticoagulant treatment, and thromboprophylaxis in patients 2 years of age and older with congenital heart disease who have undergone the Fontan procedure. A new oral suspension formulation of Xarelto has also been approved by the FDA. According to Johnson & Johnson, the maker of Xarelto, the new oral suspension offers flexible, body weight-adjusted dosing options for pediatric patients-an alternative to injectable anticoagulants that have long been the standard of care.
Second COVID-19 booster shot approved for patients age 50 and older, some immunocompromised
The FDA approved a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people age 50 and older and for certain immunocompromised individuals. Current evidence suggests there is some waning of vaccine protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. A second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns, the FDA states. The authorization is only for the Pfizer-BioNTech and Moderna COVID-19 vaccines. The FDA's authorization of a single booster with these vaccines for other age groups remains unchanged.
The second booster dose of the Pfizer-BioNTech COVID-19 vaccine can be administered to individuals 50 years of age and older at least 4 months after they receive a first booster dose of any authorized or approved COVID-19 vaccine; a second booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromisations (including those who have undergone solid organ transplantation or who are living with conditions considered to have an equivalent level of immunocompromisation) at least 4 months after receiving a first booster dose of any authorized or approved COVID-19 vaccine.
A second booster of the Moderna COVID-19 vaccine can be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the abovementioned kinds of immunocompromisation.
First generic of Restasis approved for chronic dry eye
The FDA approved the first generic version of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. The new generic of Restasis is being marketed by Viatris Pharmaceuticals. It is the first generic of Restasis to be approved by the FDA since Restasis was first marketed in the US nearly 20 years ago.
Solosec approved for bacterial vaginosis, trichomoniasis in adolescents
The FDA has approved the expanded use of Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in female patients 12 years of age and older and for the treatment of trichomoniasis in patients 12 years of age and older. Solosec is the first and only single-dose oral prescription antimicrobial approved for the treatment of both trichomoniasis and BV. One oral dose of Solosec contains a complete course of treatment.
Solosec is taken by sprinkling an entire packet of granules onto applesauce, yogurt, or pudding. The entire dose should be taken at once and finished within 30 minutes. The granules should not be chewed or crunched and should not be taken by dissolving in any liquid. The use of alcohol during treatment with Solosec and for 2 days after taking Solosec should be avoided.