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The FDA has approved Ebanga (ansuvimab-zykl) for the treatment of Ebola. Ebanga is approved for treatment of infection caused by Zaire ebolavirus in adult and pediatric patients (including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection). Ebanga is the only FDA approved, single injection Ebola treatment that is available in a lyophilized form.
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The FDA has approved Gemtesa (vibegron), a beta-3 adrenergic receptor agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. This approval marks the first new oral branded OAB medication approved by the FDA since 2012.
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The FDA has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) of the face or scalp. Klisyri is a novel, topical first-in-class microtubule inhibitor that represents a significant step forward in the treatment of AK due to its short treatment protocol (once daily application for 5 days) and proven efficacy and safety profile. Klisyri will be launched in the US during the first quarter of 2021.
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The FDA has approved Margenza (margetuximab-cmkb), in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Margenza is slated to be available in March 2021.
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The FDA has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Orgovyx, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone receptor antagonist for men with advanced prostate cancer. Orgovyx is expected to be available in January 2021.
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The FDA has approved Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener's granulomatosis), and microscopic polyangiitis. Riabni will be made available in the US in January 2021.
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The FDA has approved the first generic of glucagon for injection USP, 1mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia, which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous.
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The FDA has approved Tagrisso (osimertinib) for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer after tumor resection with curative intent. Tagrisso is indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
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Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% rubbing alcohol in 33.81 oz. clear plastic bottles, to the consumer level. FDA analysis of the product revealed it is contaminated with methanol.
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Fresenius Kabi USA is voluntarily recalling a single lot of ketorolac tromethamine injection, USP, 30mg/mL, 1mL fill in a 2mL amber vial to the user level due to the presence of particulate matter found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.
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Nostrum Laboratories, Inc. is voluntarily recalling one lot of metformin HCl ER tablets, USP 750mg (generic equivalent to Glucophage tablets), to the consumer level. The metformin HCl ER tablets have been found to contain levels of nitrosamine impurities above the ADI limit of 96ng/day as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020.
Learn more about the Nostrum Laboratories metformin HCl ER recall
Precision Dose, Inc. is voluntarily recalling all lots of chlorhexidine gluconate oral rinse USP, 0.12%, 15mL unit dose cups bearing an expiration date from 1/31/2021 – 02/28/2022, to the consumer level. The product may be contaminated with the bacteria Burkholderia lata.
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Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG: 2020/05/10 L/N: 20200510-3 of Wash-Free Hand Sanitizer 50mL, 100mL, 300mL and Wash Free Hand Sanitizer 300mL lot 2020/05/11 and Thrifty White Pharmacy Wash-Free Hand Sanitizer 300mL lot 2020/05/11 to the consumer level. The products are being recalled due to the potential presence of methanol.
Learn more about the Shane Erickson wash-free hand sanitizer recall
Sunstar Americas, Inc. is voluntarily recalling Paroex chlorhexidine gluconate oral rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020.
Learn more about the Sunstar Americas Paroex chlorhexidine gluconate oral rinse recall
The FDA is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk. The FDA purchased these products on Amazon and eBay, and agency testing found that the products contain active pharmaceutical ingredients not listed on their labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking.
Learn more about avoiding certain male enhancement and weight loss products
The FDA issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the FD&C Act. The warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions. The letters include CBD products that are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food and the impermissible marketing of CBD products as dietary supplements. Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye.
Learn more about companies illegally selling CBD products