CLINICAL ROLE -
Pharmacist Spotlight: Joanna Lewis, PharmD, MBA
Fun Facts: Are Antacids Just Chalk?
Condition State Management: Substance Abuse
Generic Product News - November 2023
The products include Doxycycline Hyclate Delayed-Release Tablets, Lisdexamfetamine Dimesylate Capsules, Calcium Gluconate in
Sodium Chloride Injection, Estradiol Tablets USP
Rx Product News - November 2023
The products include Crovalimab, Dapagliflozin, Secukinumab, Roflumilast
OTC Product News: November 2023
The products include Reserve Sleep Gummies, Menopause Stage
Indicator, Organic Ashwagandha Gummies, and Precise Pain Relieving Cream.
FDA Approves Faricimab for Macular Edema Following Retinal Vein Occlusion
Faricimab is the first and only bispecific antibody granted FDA approval for treatment of the eye.
FDA Approves Mirikizumab for Moderately to Severely Active Ulcerative Colitis
Mirikizumab-mrkz (Omvoh; Eli Lilly and Company) is the first IL-23p19 antagonist approved for adult patients with moderately to severely active ulcerative colitis.
Subcutaneous Lecanemab Found Equally Effective as IV Version in Alzheimer Disease Treatment
A weekly dose of injectable lecanemab-irmb (Leqembi) could allow patients with Alzheimer disease to receive the drug at home instead of visiting an infusion center twice per month.
CDC Issues Alert to Address Shortage of RSV Treatment Nirsevimab
Nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) is a monoclonal antibody approved to prevent against respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants under 8 months of age born during or entering their first RSV season.
Phase 3 Trial Begins for Combination Influenza and COVID-19 Vaccine
mRNA-1083 is an investigational combination vaccine designed to prevent influenza and COVID-19.
FDA Approves Infliximab-dyyb for Inflammatory Bowel Disease
Infliximab-dyyb (Zymfentra; Celltrion USA) is a subcutaneous treatment for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn disease.
Condition State Management: Stroke Watch
FDA Approves Pentavalent Vaccine for Most Common Serogroups That Cause Meningococcal Disease
Penbraya (Pfizer Inc) is the first and only approved pentavalent vaccine that confers protection against the most common meningococcal serogroups—A, B, C, W-135, and Y, in individuals 10 through 25 years of age.
FDA Approves Bimekizumab for Moderate-To-Severe Plaque Psoriasis
Bimekizumab is a novel, humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-7A and IL-17F, which are key cytokines driving inflammatory processes in plaque psoriasis.
FDA Approves Pembrolizumab Resectable Non–Small Cell Lung Cancer
Pembrolizumab (Keytruda) gains its sixth approval in non–small cell lung cancer (NSCLC), with the latest indication in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a monotherapy for the post-surgical adjuvant treatment of patients with resectable NSCLC.
FDA Approves Nivolumab for Completely Resected Stage IIB or Stage IIC Melanoma in Adult, Pediatric Patients
In clinical trials, nivolumab (Opdivo) demonstrated a statistically significant improvement in recurrence-free survival compared to placebo in eligible patients with stages IIB, IIC, III, and stage IV completely resected melanoma.
FDA Approves Encorafenib Plus Binimetinib Combination for Non-Small Cell Lung Cancer
Encorafenib (Braftovi; Pfizer Inc) and binimetinib (Mektovi; Pfizer Inc) approved for the treatment of patients with metastatic non-small cell lung cancer who harbor a BRAF V600E mutation.
Study Highlights Impact of Preventive Strategies for RSV Hospitalizations in Pediatric Patients
Study shows a a significant burden of hospitalizations associated with respiratory syncytial virus during the 2021-2022 season compared with the prepandemic period.
FDA Issues Emergency Use Authorization to Novavax’s COVID-19 Vaccine 2023-24 Formula
NVX-CoV2601 vaccine adjuvanted 2023-2024 formula granted EUA for the prevention of COVID-19 in those 12 years of age and older.
Bosutinib Approved by FDA for Pediatric Patients With Chronic Myelogenous Leukemia
Bosutinib (Bosulif) is indicated to treat pediatric patients with Philadelphia chromosome–positive chronic-phase chronic myelogenous leukemia that is newly diagnosed, resistant, or intolerant to previous therapy.
Menopause Condition Watch
FDA Approves Momelotinib to Treat Myelofibrosis Patients With Anemia
Most patients with myelofibrosis will develop anemia over the course of the disease, with more than 30% discontinuing treatment as a result.
Generic Product News - September 2023
Products include Cyanocobalamin Nasal Spray, Chlorpromazine
Hydrochloride Tablets USP, Tiotropium Bromide
Inhalation Powder, 18 mcg/
capsule, and Sevelamer Hydrochloride Tablets USP.
September 2023: RX Product News
Products include Nirsevimab-alip, Remdesivir, Inclisiran, and Lecanemab-irmb.
OTC Product News: September 2023
Products include prose skin care, ESPADA 2 plus, hair blend line, and a warm eye mask.
FDA Issues Tentative Approval to Abacavir/Dolutegravir/Lamivudine Combo to Treat HIV in Pediatric Patients
The fixed-dose abacavir/dolutegravir/lamivudine combination is indicated for the once-daily treatment of children weighing at least 6 kg to <25 kg with HIV-1 infection.
FDA Approves Luspatercept-aamt for First-Line Treatment of Anemia in Adults With Lower-Risk Myelodysplastic Syndromes
Luspatercept-aamt (Reblozyl) approved to treat adults with very low- to intermediate-risk myelodysplastic syndrome who may require regular red blood cell transfusions.
Fun Facts: August 2023
August Generic Product News
This months generic product news includes azithromycin tablets, minocycline hydrochloride tablets, carboprost tromethanmine injection, and tadalafil tablets.
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