Pharmacy Bulletin 11-01-21

Pharmacy Bulletin 11-01-21

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

VativoRx Bottle update

Zimhi Approved

Adamis Pharmaceuticals was granted approval from the U.S. Food and Drug Administration (FDA) for Zimhi™ (naloxone) injection, 5mg/0.5mL. A higher strength than naloxone products previously available in the U.S., it is indicated for children, teens and adults as a temporary reversal of overdoses with an opioid drug. A dose of Zimhi is given as soon as an overdose is observed or suspected, based on the patient’s breathing difficulty and/or unconsciousness. Oct. 15, 2021

New Pain Drug, Seglentis, Approved

The FDA approved Esteve Pharmaceuticals’ Seglentis® (celecoxib 56mg/tramadol 44mg) tablets. Using a unique process, the drug combines crystals of a non-steroidal anti-inflammatory drug (NSAID) with an opioid pain reliever. It is indicated to treat adults who have severe acute pain that needs an opioid, but that has not been helped by other therapy options. Oct. 15, 2021

New Strength and Expanded Pediatric Indication for Biktarvy

A new strength of Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) tablets was FDA approved to treat patients who weigh between 14kg (about 31 pounds) and 25kg (55 pounds). Biktarvy is a once-daily combination of antiviral drugs used to treat HIV-1 infection. Oct. 7, 2021

Dupixent Pediatric Indication Extended

Dupixent® (dupilumab – Regeneron) originally was FDA approved in March 2017 to treat adults who have atopic dermatitis. In October 2018, it received an additional approval as an add-on to standard asthma care as maintenance treatment for patients at least 12 years old who have moderate-to-severe eosinophilic asthma or oral corticosteroid-dependent asthma.

First Interchangeable Biosimilar for Humira Designated

The FDA approved Cyltezo® (adalimumab-adbm – Boehringer Ingelheim) injection as interchangeable with Humira® (adalimumab – AbbVie). It is a tumor necrosis factor (TNF) inhibitor that originally was FDA approved in 2017 as a biosimilar. Oct. 15, 2021

Irbesartan and Irbesartan with Hydrochlorothiazide – Recall

Lupin Pharmaceuticals recalled all of its irbesartan and irbesartan with hydrochlorothiazide tablets. Some lots of the raw materials used to make the tablets tested above the allowed limits for a probable carcinogenic impurity, N-nitrosoirbesartan. An angiotensin receptor blocker (ARB), irbesartan is used predominantly to reduce high blood pressure with or without the diuretic, hydrochlorothiazide. Lupin stopped marketing the recalled products in January. Oct. 14, 2021

COVID-19 Vaccines – FDA authorizes Moderna, Janssen boosters and “mix and match” vaccines

The FDA authorized booster doses for Moderna and Janssen’s COVID-19 vaccines for certain populations. In addition, the FDA authorized heterologous (or mix and match) booster doses for each of the available COVID-19 vaccines. October 20, 2021

COVID-19 Vaccines – CDC’s ACIP votes to recommend vaccine boosters

The Center for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) met on October 21, 2021 to discuss the updated EUAs and to issue recommendations for use.

Merck – Recall of Cubicin® (daptomycin)

The FDA announced a voluntary, user-level recall of one lot of Merck’s Cubicin (daptomycin) 500 mg injection because of a customer complaint reporting that a piece of glass was found in a vial of Cubicin after reconstitution. October 20, 2021

COVID-19 Vaccines – FDA advisors discuss Pfizer/BioNTech’s vaccine for patients 5 to < 12 years

The FDA convened a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to discuss expanding the emergency use authorization (EUA) for Pfizer/BioNTech’s COVID-19 vaccine to include children between 5 and < 12 years of age. October 26, 2021

Bryant Ranch Prepack – Recall of methocarbamol

The FDA announced a voluntary, consumer-level recall of Bryant Ranch Prepack’s methocarbamol 500 mg tablets because the bottles labeled as methocarbamol 500 mg tablets have been found to contain methocarbamol 750 mg tablets. October 19, 2021

Pepaxto® (melphalan flufenamide) – Withdrawal from the U.S. market

Oncopeptides announced the withdrawal of Pepaxto (melphalan flufenamide) following a clinical trial (OCEAN) that demonstrated an overall survival in the intention to treat population with a hazard ratio of 1.104. October 22, 2021

Seglentis® (celecoxib/tramadol) – New drug approval

Esteve Pharmaceuticals announced the FDA approval of Seglentis (celecoxib/tramadol), for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. October 18, 2021

Susvimo™ (ranibizumab) – New drug approval

Genentech announced the FDA approval of Susvimo (ranibizumab), for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication. October 22, 2021

Xipere® (triamcinolone acetonide) – New drug approval

Bausch + Lomb and Clearside Biomedical announced the FDA approval of Xipere (triamcinolone acetonide), for the treatment of macular edema associated with uveitis. October 25, 2021

Dupixent® (dupilumab) – Expanded indication

Sanofi and Regeneron announced the FDA approval of Dupixent (dupilumab), as an add-on maintenance treatment of patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. October 20, 2021

Flucelvax® Quadrivalent (influenza vaccine) – Expanded indication

The FDA approved Seqirus’ Flucelvax Quadrivalent (influenza vaccine), for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. Flucelvax Quadrivalent is approved for use in persons 6 months of age and older. October 14, 2021

Vimpat® (lacosamide) – Expanded indication

The FDA approved UCB’s Vimpat (lacosamide), for the treatment of partial-onset seizures in patients 1 month of age and older. October 14, 2021