CLINICAL ROLE -
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.
August RX Product News
August OTC Product News
FDA Grants Accelerated Approval to Elranatamab-bcmm for Relapsed or Refractory Multiple Myeloma
Elranatamab-bcmm (Elrexfio; Pfizer) is a BCMA-CD3-targeted bispecific antibody approved for adults with relapsed or refractory multiple myeloma who were previously administered at least 4 lines of therapy that included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
FDA Approves New Combination Therapy for BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Niraparib and abiraterone acetate (Akeega; Janssen Pharmaceutical Companies of Johnson & Johnson) is the first-and-only dual action tablet that combines a PARP inhibitor with abiraterone acetate administered with prednisone.
FDA Grants Accelerated Approval to Talquetamab-tgvs for Patients With Heavily Pretreated Multiple Myeloma
Talquetamab-tgvs (Talvey) is a first-in-class bispecific antibody that binds to GPRC5D and CD3 to induce T cell-mediated killing of GPRC5D-expressing multiple myeloma cells.
Lisaftoclax Granted FDA Clearance for Phase 3 Trial in Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Lisaftoclax is a novel, oral, small-molecule, BCL-2 selective inhibitor being evaluated for treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Pembrolizumab Produces a Sustained Response in Patients With Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma
At a median follow-up of 48.7 months, pembrolizumab monotherapy produced an investigator-assessed objective response rate of 41.5% and a 20.8% complete response rate in patients with relapsed/refractory primary mediastinal large B-cell lymphoma.
Study Finds Low Rate of Asymptomatic C Difficile Carriage in Hospitals
CDI is difficult to contain in health care settings because some patients are unknowing carriers of the toxigenic strains of the infection.
CDC Advisory Committee on Immunization Practices Recommends Nirsevimab-alip to Prevent RSV in Infants
CDC Advisory Committee on Immunization Practices voted 10 to 0 to recommend the routine use of nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns and infants.
FDA Approves Expanded Indication of Ebola Zaire Vaccine for Individuals 12 Years of Age and Older
Ervebo was found to be 100% effective after vaccination in preventing the onset of Ebola virus symptoms after more than 10 days.
FDA Approves Dostarlimab Combination for Primary Advanced or Recurrent Endometrial Cancer
Dostarlimab-gxly (Jemperli) approved in combination with carboplatin and paclitaxel for the treatment of adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.
Second OTC Opioid Overdose Reversal Medication Approved by FDA
The approval of RiVive naloxone hydrochloride nasal spray for nonprescription use provides another tool to help quickly reverse the effects of opioid overdose.
Do Pharmaceutical Brand Colors Affect Consumer Buying Decisions?
A company’s choice of color for branding and logo design may impact how consumers feel about the brand and could influence buyer decision-making.
July 2023 Generic Product News
This months generic product news includes Nitisinone capsules, Prednisolone tablets, Carboprost Tromethamine injections, and Methsuximide capsules.
July 2023 OTC Product News
This months OTC products include brain fuel, SPF 50 mineral sunscreen, women's ensemble, and kids SPF 50 gentle lotion sunscreen.
Dental Hygiene May Play Significant Role in Cognitive Decline, Study Suggests
Tooth loss and gum disease may play a role in the health of the brain area that controls thinking and memory.
Abivertinib Shows Promise Treating Marginal Zone Lymphoma
Irreversible Bruton tyrosine kinase inhibitor produces positive results in patients with relapsed/refractory marginal zone lymphoma.
Immunoprophylaxis Guidance for RSV Not Aligned With Current Hospitalization Patterns, Study Finds
Investigators urge policymakers to establish flexible models that maximize coverage when respiratory syncytial virus activity is high and minimize unnecessary doses when viral activity is low.
Study Links 23-Valent Pneumococcal Vaccine to Injection Site Necrosis
Despite injection site adverse effects, the overall benefit-risk balance for pneumococcal vaccination remains favorable.
FDA Expands Label for Inclisiran to Include Adults With High LDL-C, Increased Risk of Heart Disease
The updated label for inclisiran (Leqvio) includes patients with comorbidities, such as hypertension and diabetes, who have yet to experience a cardiovascular event.
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