UltiMed Withdrawal of UltiCare pen needles
UltiMed announced a consumer-level withdrawal of one lot of UltiCare pen needles 6 mm x 31 G due to a report received that the inner box and case label expiration date is incorrectly labeled as February 28, 2006; the correct expiration date is February 28, 2026. June 15, 2021
Epclusa (sofosbuvir/velpatasvir) Expanded indication, new formulation approval
Gilead announced the FDA approval of Epclusa (sofosbuvir/velpatasvir), for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis and with decompensated cirrhosis for use in combination with ribavirin. June 10, 2021
Mavyret (glecaprevir/pibrentasvir) Expanded indication, new formulation approval
The FDA approved AbbVies Mavyret (glecaprevir/pibrentasvir). June 10, 2021
Prevnar 20 (pneumococcal 20-valent conjugate vaccine) New drug approval
Pfizer announced the FDA approval of Prevnar 20 (pneumococcal 20-valent conjugate vaccine), for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. June 8, 2021
Banzel (rufinamide) First-time generic
Hikma – Mylan, Glenmark and Camber/Hetero launched AB-rated generic versions of Eisais Banzel (rufinamide) 200 mg and 400 mg tablets. June 1, 2021
Kaletra (lopinavir/ritonavir) First-time generic
Camber launched an AB-rated generic version of AbbVies Kaletra (lopinavir/ritonavir) tablets. June 7, 2021
Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) Expanded indication, new strength
Vertex announced the FDA approval of Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor), for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data. June 9, 2021