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Pharmacy Bulletin 04-23-21

Pharmacy Bulletin 04-23-21

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

VativoRx Bottle update

Nextstellis® (drospirenone/estetrol) – New drug approval

Mayne Pharma and Mithra Pharmaceuticals announced the FDA approval of Nextstellis (drospirenone/estetrol), for use by females of reproductive potential to prevent pregnancy. April 16, 2021

bamlanivimab – Emergency use authorization revoked

The FDA revoked the emergency use authorization (EUA) for Eli Lilly’s bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and certain pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 vial testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. April 16, 2021

J&J COVID-19 Vaccine – Use Paused Due to Possible Safety Concern

The CDC and FDA recommended a pause in the use of the Johnson & Johnson (J&J) coronavirus vaccine out of an abundance of caution due to six reports of blood clots. April 13, 2021

Lyrica® CR (pregabalin) – First-time generic

Novadoz/MSN Pharmaceuticals and Alvogen launched AB-rated generic versions of Pfizer’s Lyrica CR (pregabalin) extended-release tablets. April 13, 2021

Evekeo ODT™ (amphetamine sulfate) – Expanded indication, new strength

The FDA approved Arbor Pharmaceuticals’ Evekeo ODT (amphetamine sulfate), for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 3 to 17 years of age. April 16, 2021

Opdivo® (nivolumab) – New indication

Bristol Myers Squibb announced the FDA approval of Opdivo (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. April 16, 2021

Trodelvy® (sacitzumab govitecan-hziy) – New indication

Gilead Sciences announced the FDA approval of Trodelvy (sacituzumab govitecan-hziy), for the treatment of locally advanced or metastatic urothelial cancer (UC) in adult patients who have previously received platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. April 13, 2021

Xolair® (omalizumab) – Updated dosing

Genentech announced the FDA approval of Xolair (omalizumab) prefilled syringe for self-injection across all its approved indications. April 12, 2021