COVID-19 Vaccines – FDA Advisors Discuss Vaccine Boosters at 2 Day Meeting

The Food and Drug Administration convened a Vaccine and Biologic Products Advisory Committee (VRBPAC) to discuss expanding the emergency use authorization (EUA) for Moderna’s COVID-19 vaccine and Janssen’s COVID-19 vaccine to include a booster dose. The Pfizer COVID-19 vaccine already has been granted EUA for a booster dose. October 14 & 15, 2021

Rethymic Receives FDA Approval

Enzyvant’s Rethymic® (allogeneic processed thymus tissue-agdc) was approved by the U.S. Food and Drug Administration (FDA). It is the first therapy that targets the underlying cause of an ultra-rare condition, pediatric congenital athymia — including a condition known as DiGeorge syndrome. Oct. 8, 2021

Third Indication for Dextenza

The FDA approved a new indication to relieve itchy eyes resulting from allergic conjunctivitis for Dextenza® (dexamethasone ophthalmic insert) 0.4 mg. Made by Ocular Therapeutix, Dextenza is a corticosteroid that is implanted intracanalicularly – into a small channel in the tear duct. Although the preservative-free insert can be removed if needed, Dextenza gradually dissolves, releasing dexamethasone for up to 30 days before being cleared from the eye. Its use replaces the need for multiple daily eye drop applications. Oct. 8, 2021

Verzenio Gets New indication

Verzenio® (abemaciclib – Eli Lilly and Company) tablets was FDA approved for adjuvant treatment of adults who have early breast cancer that is at high risk of recurring, that has spread to lymph nodes and that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-).

FDA Approves Keytruda to Treat Cervical Cancer

The FDA approved a new indication for Keytruda® (pembrolizumab – Merck) injection. It now is the first programmed death-ligand 1 (PD-L1) inhibitor that is FDA approved, in combination with chemo (paclitaxel and cisplatin or carboplatin) and/or bevacizumab, to treat some advanced cervical cancers. Oct. 12, 2021

Lidocaine Recall

Teligent Pharma recalled additional lots of lidocaine topical solution, 4% in 50mL bottles. Retention testing of the recalled lots found it to be super potent. It is used as topical anesthesia for mucosal surfaces of the nose, mouth and throat. High doses can lead to systemic toxicity that can include serious, potentially fatal, central nervous system (CNS) and cardiac effects — especially for pediatric and elderly patients. Oct. 12, 2021