Zydus – Recall of acyclovir injection

Zydus announced a voluntary, user-level recall of four lots of acyclovir 50 mg/mL injection after receiving several complaints of crystallization in vials. April 2, 2021

Apotex – Recall of guanfacine

Apotex announced a voluntary, consumer-level recall of three lots of guanfacine 2 mg extended-release tablets because of trace amounts of quetiapine fumarate in one lot. March 31, 2021

Abecma™ (idecabtagene vicleucel) – New orphan drug approval

The FDA announced the approval of Bristol Myers Squibb and bluebird bio’s Abecma (idecabtagene vicleucel), for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. March 27, 2021

Myrbetriq®, Myrbetriq® Granules (mirabegron extended-release) – New indication, new formulation approval

Astellas Pharma announced the FDA approval of Myrbetriq (mirabegron) tablets, for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. March 26, 2021

Roszet (rosuvastatin/ezetimibe) – New drug approval

The FDA approved Althera Pharmaceuticals’ Roszet (rosuvastatin/ezetimibe), in adults: as an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C) and alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. March 23, 2021

Exparel® (bupivacaine) – Expanded indication

Pacira BioSciences announced the FDA approval of Exparel (bupivacaine), in patients aged 6 years and older for single-dose infiltration to produce postsurgical local analgesia. March 22, 2021