Pharmacy Bulletin 08-24-21

Pharmacy Bulletin 08-24-21

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

VativoRx Bottle update

Ticovac™ (tick-borne encephalitis vaccine) – New vaccine approval

Pfizer announced the FDA approval of Ticovac (tick-borne encephalitis vaccine), for active immunization to prevent tick-borne encephalitis (TBE). Ticovac is approved for use in individuals 1 year of age and older. August 13, 2021

Welireg™ (belzutifan) – New drug approval

The FDA announced the approval of Merck’s Welireg (belzutifan), for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. August 13, 2021

Durezol® (difluprednate) – First-time generic

Cipla announced the FDA approval of an AB-rated generic version of Alcon’s Durezol (difluprednate) ophthalmic emulsion. August 12, 2021

Keytruda® (pembrolizumab), Lenvima® (lenvatinib) – Expanded indication

The FDA approved Merck’s Keytruda (pembrolizumab), in combination with Eisai’s Lenvima (lenvatinib), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). August 10, 2021

Mirena® (levonorgestrel-releasing intrauterine system) – Expanded indication

The FDA approved Bayer’s Mirena (levonorgestrel-releasing intrauterine system), for prevention of pregnancy for up to 7 years; replace after the end of the seventh year. August 11, 2021

Pfizer-BioNTech and Moderna COVID-19 vaccines – Emergency use authorization updated for additional dose for certain immunocompromised individuals

The FDA approved an amendment to the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to allow for the use of an additional dose in certain immunocompromised individuals. August 12, 2021

Xywav® (calcium/magnesium/potassium/sodium oxybates) – New indication

Jazz Pharmaceuticals announced the FDA approval of Xywav (calcium/magnesium/potassium/sodium oxybates), for the treatment of idiopathic hypersomnia (IH) in adults. August 12, 2021

Pfizer – Expansion of recall of Chantix® (varenicline)

Pfizer announced an expansion of the voluntary consumer-level recall of Chantix (varenicline) tablets to include four additional lots due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established acceptable daily intake (ADI) level. August 16, 2021