Bryant Ranch Repack – Recall of spironolactone

The FDA announced a voluntary, patient-level recall of four lots of Bryant Ranch Repack spironolactone tablets because some prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg tablets. This recall was originally announced by Bryant Ranch Repack on January 29, 2021. March 9, 2021

Sagent – Recall of phenylephrine injection

Sagent announced a voluntary, user-level recall of three lots of phenylephrine injection as the result of a customer complaint due to potentially loose crimped vial overseals. A non-integral crimped vial overseal may result in a non-sterile product. March 11, 2021

Fotivda® (tivozanib) – New drug approval

AVEO Oncology announced the FDA approval of Fotivda (tivozanib), for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. March 10, 2021

Kimyrsa™ (oritavancin) – New drug approval

Melinta Therapeutics announced the FDA approval of Kimyrsa (oritavancin), for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of Gram-positive microorganisms Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only). March 15, 2021

Fabrazyme® (agalsidase beta) – Expanded indication

Sanofi announced the FDA approval of Fabrazyme (agalsidase beta), for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. March 12, 2021