Pharmacy Bulletin 06-18-21

Pharmacy Bulletin 06-18-21

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

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