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  • FDA Drug Updates

    FDA New Approvals

    Adlarity

    The FDA has approved Adlarity (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the Alzheimer’s type. Learn more about Adlarity

    Carvykti

    The FDA has approved Carvykti (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Learn more about Carvykti

    Enjaymo

    The FDA has approved Enjaymo (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Enjaymo is the first approved treatment for people with CAD and works by inhibiting hemolysis. Learn more about Enjaymo

    Fleqsuvy

    The FDA has approved Fleqsuvy (baclofen) oral suspension, 25mg per 5 mL (5mg/mL), concentrated formulation for the treatment of spasticity from multiple sclerosis or patients with spinal cord injuries and other spinal cord diseases. Learn more about Fleqsuvy

    NephroScan

    The FDA has approved NephroScan (kit for the preparation of technetium tc 99m succimer injection), a radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adult and pediatric patients, including term neonates. Learn more about NephroScan

    Norliqva

    The FDA has approved Norliqva (amlodipine) oral solution for hypertension in adults and children aged 6 years and older, to lower blood pressure, and for coronary artery disease (chronic stable angina, vasospastic angina (Prinzmetal’s or variant angina) and angiographically documented coronary artery disease in patients without heart failure or an ejection fraction <40%). Learn more about Norliqva

    Pyrukynd

    The FDA has approved Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, a rare, debilitating, lifelong hemolytic anemia. Pyrukynd is a first-in-class, oral PK activator and the first approved disease-modifying therapy for this disease. Learn more about Pyrukynd

    Vonjo

    The FDA has approved Vonjo (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50×109/L. Vonjo is a novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK1. Learn more about Vonjo

    FDA First-Time Generic Approvals

    Apokyn

    The FDA has approved the first generic of Apokyn (apomorphine hydrochloride injection) drug cartridges to treat hypomobility “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease. Learn more about Apokyn

    Symbicort

    The FDA has approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients aged 6 years and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. Learn more about Symbicort

    FDA New Indications

    Jardiance

    The FDA has approved Jardiance (empagliflozin) 10mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Learn more about Jardiance

    Lynparza

    The FDA has approved Lynparza (olaparib) for the adjuvant treatment of patients with germline BRCA-mutated HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. Learn more about Lynparza

    Opdivo

    The FDA has approved Opdivo (nivolumab) 360mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4cm or node positive) non-small cell lung cancer in the neoadjuvant setting. Learn more about Opdivo

    Rinvoq

    The FDA has approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. This FDA approval is the first indication for Rinvoq in gastroenterology. Learn more about Rinvoq

    Solosec

    The FDA has approved expanded use of Solosec (secnidazole) in the treatment of bacterial vaginosis for female patients aged 12 years and older and in the treatment of trichomoniasis for all patients aged 12 years and older. Learn more about Solosec

    Xigduo XR

    The FDA has approved Xigduo XR (dapagliflozin/metformin HCl) extended-release tablets for the inclusion of a new indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. Learn more about Xigduo XR

    FDA Recalls

    ABC Sales 1 Mac Daddy Red and Purple Dietary Supplements

    ABC Sales 1 is voluntarily recalling Mac Daddy Red capsules, Lot 1230004, Exp 03/30/2024 and Mac Daddy Purple capsules, Lot 1230005, Exp 03/30/2024, to the consumer level. Laboratory analysis found Mac Daddy Red capsules to be tainted with sildenafil and tadalafil and Mac Daddy Purple capsules to be tainted with tadalafil. Learn more about the ABC Sales 1 Mac Daddy Red and Purple dietary supplements recall

    B. Braun Medical Sodium Chloride for Injection

    B. Braun Medical is voluntarily recalling five lots of 0.9% sodium chloride for injection USP 250mL in Excel within the US, to the hospital/user level. The voluntary recall has been initiated due to fluid leakage or low fill volume of the respective containers. Learn more about the B. Braun Medical sodium chloride for injection recall

    Celebrate Today Red Mammoth Capsules

    Celebrate Today is voluntarily recalling lot number DK1027, Exp 08/01/2023 of Red Mammoth capsules to the consumer level. Laboratory analysis has found the product to be tainted with sildenafil and tadalafil. Learn more about the Celebrate Today Red Mammoth capsules recall

    Family Dollar Products

    Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the FDA that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas, from January 1, 2021 through the present, due to the presence of rodents and rodent activity at Family Dollar Distribution Center 202. Products covered by this retail level recall include all: (i) drugs; (ii) medical devices; (iii) cosmetics; (iv) dietary supplements; and (v) human and animal (pet) food products. Learn more about the Family Dollar Products recall

    Fresenius Kabi Sodium Acetate Injection

    Fresenius Kabi is voluntarily recalling seven lots of sodium acetate injection, USP, 400mEq/100mL (4mEq/mL), 100mL fill in a 100mL vial, to the user level, due to the presence of particulate matter found in reserve and/or stability sample vials. Learn more about the Fresenius Kabi sodium acetate injection recall

    Junp MegMan Performance Booster Capsules

    Junp is voluntarily recalling Lot number 2010291, Exp Date: 01/07/2024 of MegMan Performance Booster capsules, packaged in 10-count blisters packaged in a carton, to the consumer level. Laboratory analysis has found the product to be tainted with tadalafil. Learn more about the Junp MegMan Performance Booster capsules recall

    Olympia Pharmacy Compounded Injectables

    Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, sermorelin, sincalide, hydroxocobalamin, and NAD, compounded injectables, to the consumer level. These compounded products were found to be out-of-specification. Learn more about the Olympia Pharmacy compounded injectables recall

    Positive-Health Rise Up Red Edition Capsules

    Positive-Health is voluntarily recalling lot number 48658908 with Expiry 9/9/23 of Rise Up Red Edition capsules packaged in 10-count blisters packaged in a carton to the consumer level. Laboratory analysis has found the product to be tainted with tadalafil. Learn more about the Positive-Health Rise Up Red Edition capsules recall

    Your Favorite Shop The Red Pill

    Your Favorite Shop is voluntarily recalling lot # 26436989. Expiry 10/30/2023 of The Red Pill, packaged in 10-count blisters packaged in a carton, to the consumer level. Laboratory analysis has found the product to be tainted with tadalafil. Learn more about the Your Favorite Shop The Red Pill recall