FDA New Approvals
The FDA has approved Danyelza (naxitamab-gqgk) 40mg/10mL. Danyelza is indicated, in combination with granulocyte-macrophage colony-stimulating factor, for the treatment of pediatric patients aged 1 year and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval regulation based on overall response rate and duration of response.
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Gallium 68 PSMA-11
The FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), the first drug for positron emission tomography imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen levels. Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an intravenous injection.
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The FDA has approved Hetlioz (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis syndrome (SMS). Hetlioz is the first FDA-approved medication for patients with SMS. Hetlioz capsules, for adults with SMS, will be immediately available, and the Hetlioz LQ liquid formulation, for children with SMS, is expected to be available in the first quarter of 2021.
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The FDA has approved Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency confirmed by genetic testing. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.
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FDA Labeling Changes
Januvia, Janumet, and Janumet XR
The FDA has approved labeling changes stating that Januvia (sitagliptin), Janumet (metformin HCl/sitagliptin), and Janumet XR (metformin HCl/sitagliptin extended-release) are not proven to improve glycemic control in pediatric patients aged 10 to 17 with type 2 diabetes. The drugs are approved to improve blood sugar control in adults aged 18 and older with type 2 diabetes.
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FDA New Indications
The FDA has approved Gavreto (pralsetinib) for the treatment of patients with RET-altered thyroid cancers. The accelerated approval expands the labeled indications for Gavreto to include adult and pediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Gavreto is a once-daily oral precision therapy designed to potently and selectively target RET alterations that drive multiple tumor types.
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The FDA has approved Saxenda (liraglutide) injection 3mg for use in the
treatment of obesity in adolescents aged 12 through 17 years with a body weight
above 60kg and an initial body mass index corresponding to 30kg/m2 or greater for
adults, as an adjunct to a reduced-calorie diet and increased physical
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AvKARE Sildenafil and Trazodone
AvKARE is voluntarily recalling one lot of sildenafil 100mg tablets and one lot of trazodone 100mg tablets, to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a third-party facility.
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Fusion Health and Vitality CORE Essential Nutrients and Immune Boost Sublingual Vitamin D3
Fusion Health and Vitality is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost labeling was found to contain statements that caused it to become an unapproved new drug under FDA labeling laws. Hordenine HCl is possibly unsafe when taken by mouth.
Learn more about the Fusion Health and Vitality CORE and Immune Boost recall
MPM Medical Regenecare HA Hydrogel
MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel
to the consumer level. Following two customer complaints of visible
contamination, the product was found to be contaminated with the bacteria Burkholderia cepacia.
Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result
in local skin infections.
Learn more about the Regenecare HA Hydrogel recall
Torrent Pharmaceuticals Anagrelide Capsules
Torrent Pharmaceuticals is voluntarily recalling one lot of anagrelide capsules, USP, to the consumer level, due to dissolution test failure detected during routine quality testing. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body.
Learn more about the Torrent Pharmaceuticals anagrelide capsules recall
WishGarden Herbs Cord Care and Goldenseal Powder
WishGarden Herbs is voluntarily recalling, to the consumer level, 14
lots of Cord Care and Goldenseal Powder products produced after 7/26/18 with
expiration dates between 7/26/18 and 9/1/20. After receiving notice of a supply
chain issue, WishGarden has determined these products were manufactured using
ingredients potentially contaminated with Cronobacter sakazakii bacteria.
Learn more about the WishGarden Herbs Cord Care and Goldenseal Powder recall
WishGarden Herbs Happy Ducts Compress
WishGarden Herbs is voluntarily recalling one lot of Happy Ducts
Compress to the consumer level. After becoming aware of a possible supply chain
contamination, a retained product was found to contain the Cronobacter sakazakii bacteria.
WishGarden has initiated this recall due to the possible bacterial
contamination of Happy Ducts Compress products of lot 53664.
Learn more about the WishGarden Herbs Happy Ducts Compress recall