FDA New Approvals
The FDA has approved Jemperli (dostarlimab-gxly), a programmed death receptor-1 blocking antibody. Jemperli is indicated for the treatment of adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, who have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response.
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The FDA has approved Kimyrsa (oritavancin) for the treatment of adult
patients with acute bacterial skin and skin structure infections (ABSSSIs)
caused by susceptible isolates of designated Gram-positive microorganisms,
including methicillin-resistant Staphylococcus aureus. Kimyrsa is a lipoglycopeptide
antibiotic that delivers a complete course of therapy for ABSSSIs in a single,
one-hour, 1200mg infusion.
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The FDA has approved Kloxxado (naloxone hydrochloride) nasal spray 8mg for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. Kloxxado contains twice as much naloxone per spray as Narcan Nasal Spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important new treatment option in addressing the opioid epidemic.
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The FDA has approved Nextstellis (drospirenone/estetrol) tablets for the prevention of pregnancy. Nextstellis is the first and only contraceptive pill containing estetrol, a naturally occurring estrogen, now produced from a plant source, with a unique mechanism of action that offers potential advantages over other estrogens.
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The FDA has approved Qelbree (viloxazine) extended-release capsules for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients aged 6 to 17. The is the first novel non-stimulant treatment for ADHD in a decade.
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The FDA has approved Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, with at least one of them for metastatic disease. Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse.
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The FDA has approved Zynlonta (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma and high-grade B-cell lymphoma.
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FDA New Indications
The FDA has approved Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 inhibitor, to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
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The FDA has approved the anti-PD-1 therapy Keytruda for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.
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The FDA has approved Opdivo (nivolumab) (injection for intravenous use), in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status.
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The FDA has approved Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. This marks the second FDA approval for Sarclisa, which is also approved in combination with pomalidomide and dexamethasone for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
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The FDA has approved Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. The approval makes Yescarta the first chimeric antigen receptor T-cell therapy approved for patients with indolent follicular lymphoma, follows FDA Breakthrough Therapy Designation and a priority review, and marks the third approved indication for a Kite cell therapy.
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FDA New Dosing
The FDA has approved Xolair (omalizumab) prefilled syringe for self-injection across all approved US indications. Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps.
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A-S Medication Solutions Acetaminophen
A-S Medication Solutions is voluntarily recalling 198,350 bottles of acetaminophen extra strength 500mg tablets, 100-ct bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. This recall is being conducted to the consumer level. These OTC analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label.
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Acella Pharmaceuticals Thyroid Tablets
Acella Pharmaceuticals is voluntarily recalling certain lots of 15mg, 30mg, 60mg, 90mg, and 120mg NP Thyroid, thyroid tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be subpotent.
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BD is voluntarily recalling specified lots of the ChloraPrep Hi-Lite Orange 26mL applicator (2% w/w chlorhexidine gluconate and 70% v/v isopropyl alcohol) to the user level due to a defective applicator. In certain lots, the applicator end cap was improperly secured due to a manufacturing error. This can result in broken glass and solution dropping out of the applicator once activated.
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Church & Dwight Vitamins
Church & Dwight initiated a voluntary recall of select Vitafusion gummy products after an investigation of two consumer reports identified the possible presence of metallic mesh material in product lots manufactured in a four-day period between October 29 and November 3, 2020.
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Durisan Hand Sanitizer
Durisan announced a voluntary recall expansion of its Durisan antimicrobial hand sanitizer, nonalcohol products in various sizes to now include products that have not yet expired. The products are being recalled due to out-of-specification microbial contamination.
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NS NY Distributor Inc Premium OrgaZen 7000 and Ginseng Power 5000
NS NY Distributor Inc is voluntarily recalling all lots within expiry of Premium OrgaZen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA analysis has found the products to contain undeclared sildenafil and/or tadalafil.
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QMART IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000, and IMPERIAL Platinum 2000
QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000, and IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil.
Learn more about the QMART IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000, and IMPERIAL Platinum 2000 recall
Scentsational Soaps & Candles Hand Sanitizer
Scentsational Soaps & Candles is voluntarily recalling 5 lots of Scentsational Soaps & Candles scented hand sanitizers from the Black and White Collection and Photo Real Collection and 3 lots of Ulta Beauty Collection scented hand sanitizer spray packaged in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer level. These products are being recalled after testing revealed the presence of methanol, benzene, and acetaldehyde.
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Yolo Studio PremierZEN Extreme 3000, PremierZEN Black 5000, and Triple SupremeZEN Plus 3500
Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Black 5000, and Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil.
Learn more about the Yolo Studio PremierZEN Extreme 3000, PremierZEN Black 5000, and Triple SupremeZEN Plus 3500 recall