Pharmacy Bulletin

Pharmacy Bulletin

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

VativoRx Bottle update

Eli Lilly – Recall of Glucagon® Emergency Kit

Eli Lilly announced a voluntary, patient-level recall of one lot of Glucagon Emergency Kit for Low Blood Sugar because of a product complaint reporting that the vial of glucagon was in liquid form instead of the powder form. September 26, 2021

Opzelura™ (ruxolitinib) – New drug approval

Incyte announced the FDA approval of Opzelura (ruxolitinib) cream, for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. September 21, 2021

Chantix® (varenicline) – First-time generic

Endo announced the launch of an AB-rated generic version of Pfizer’s Chantix (varenicline) 0.5 mg and 1 mg tablets. September 22, 2021

Jakafi® (ruxolitinib) – New indication

Incyte announced the FDA approval of Jakafi (ruxolitinib), for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. September 22, 2021

Qulipta™ (atogepant) – New Approval

AbbVie announced U.S. Food and Drug Administration (FDA) approval of Qulipta™ (atogepant), an orally administered calcitonin gene-related peptide receptor (CGRP) antagonist, for prevention of episodic migraine in adults. Sept. 28, 2021

Livmarli (maralixibat)

Livmarli™ (maralixibat – Mirum Pharmaceuticals) oral solution was approved by the U.S. Food and Drug Administration (FDA). An ileal bile acid transporter (IBAT) inhibitor, it is the first drug indicated to treat children who are at least one year old and who have cholestatic pruritus caused by Alagille syndrome (ALGS). Sept. 29, 2021

Repatha® (evolocumab) – New Indication

Repatha® (evolocumab), Amgen’s proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, was U.S. Food and Drug Administration (FDA) approved, for treating patients as young as 10 years old who have heterozygous familial hypercholesterolemia (HeFH). Sept. 24, 2021

Erbitux – Approval Extension

Eli Lilly and Company received FDA approval to expand the indications for Erbitux® (cetuximab) injection. Along with Braftovi® (encorafenib – Pfizer) capsules, it is indicated as second-line or later therapy to treat adults who have metastatic colorectal cancer (CRC) that has tested positive for a BRAF V600E mutation. Sept. 24, 2021

Glucagon Emergency Kit® – Recall

Eli Lilly and Company voluntarily recalled one lot for Glucagon Emergency Kit® after discovering the vial containing the active ingredient, which should be in powder form, has a liquid formulation instead that may not be potent enough to treat an episode of low blood sugar. One patient, whose complaint led to the recall, suffered an episode of low blood sugar and due to the product failure, they subsequently had a seizure. Sept. 25, 2021

Bayer – Recall of Lotrimin® AF and Tinactin® spray products

Bayer announced a voluntary, consumer-level recall of all unexpired Lotrimin Anti-Fungal (AF) and Tinactin over-the-counter (OTC) spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, due to the presence of benzene in some samples of the products. October 1, 2021

Livmarli™ (maralixibat) – New orphan drug approval

Mirum Pharmaceuticals announced the FDA approval of Livmarli (maralixibat), for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older. September 29, 2021

Qulipta™ (atogepant) – New drug approval

AbbVie announced the FDA approval of Qulipta (atogepant), for the preventive treatment of episodic migraine in adults. September 28, 2021

Erbitux® (cetuximab) – New indication

Eli Lilly announced the FDA approval of Erbitux (cetuximab), in combination with Braftovi® (encorafenib), for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy September 28, 2021

Repatha® (evolocumab) – New indication and expanded indication

Amgen announced the FDA approval of Repatha (evolocumab), as an adjunct to diet and other low density lipoprotein-cholesterol (LDL-C)-lowering therapies in pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C. September 24, 2021

Tasigna® (nilotinib) – Expanded indication

The FDA approved Novartis’ Tasigna (nilotinib), for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy. September 23, 2021

Tecartus® (brexucabtagene autoleucel) – New indication

Gilead announced the FDA approval of Tecartus (brexucabtagene autoleucel), for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). October 1, 2021

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