FDA New Approvals
Detectnet (copper Cu 64 dotatate injection) was approved by the FDA. Detectnet is a positron emission tomography agent indicated for the localization of somatostatin receptor positive neuroendocrine tumors in adult patients.
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The FDA has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody-positive). NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng is the third approved treatment for the disorder.
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The FDA has approved Gavreto (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA approved test.
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The FDA has approved Kesimpta (ofatumumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome. Kesimpta is the first FDA approval of a self-administered, targeted B-cell therapy for these conditions, and is delivered via an autoinjector pen.
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The FDA approved Onureg (azacitidine) 300mg tablets for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
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The FDA approved the biologics license application for Sogroya (somapacitan-beco) injection 10mg/1.5mL (6.7mg/mL) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). Adults diagnosed with GHD do not produce sufficient growth hormone. Sogroya is a human growth hormone analog taken once a week by subcutaneous injection.
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FDA New Indications
The FDA approved changes to the Dovato (dolutegravir/lamivudine) product labeling to include a new indication and provide longer-term (96-week) safety and efficacy data from the GEMINI 1 and 2 trials. Dovato is to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.
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Bayshore Pharmaceuticals Metformin HCl Extended-Release Tablets
Bayshore Pharmaceuticals is voluntarily recalling one lot (18641) of metformin HCl extended-release tablets USP, 500mg, 1000 count bottles and one lot (18657) of metformin HCl extended-release tablets USP, 750mg, 100 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine levels above the acceptable daily intake limit. This product was manufactured by Beximco Pharmaceuticals Limited for US distribution by Bayshore.
Learn more about the Bayshore Pharmaceuticals metformin HCl extended-release tablets recall
Maison Terre Goldenseal Root Powder
Maison Terre is voluntarily recalling all lots of its Goldenseal Root Powder due to microbial contamination. FDA laboratory analysis of product samples found these products to be contaminated with various microorganisms. The product is a yellow powder that comes in a clear plastic bag, net weight of 1 oz. The recalled Goldenseal Root Powder was distributed nationwide in the US to customers who ordered online and purchased between the dates of January 25, 2015 and August 4, 2020.
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Mylan Amiodarone HCl and Tranexamic Acid Injections
Mylan is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of amiodarone HCl injection, USP 450mg/9mL, packaged in cartons of 10 single-dose 9mL vials and tranexamic acid injection, USP 1000mg/10mL, packaged in cartons of 10 single-dose 10mL vials. These batches are being recalled due to the potential for cartons labeled as tranexamic acid injection, USP to contain vials of amiodarone HCl injection, USP and cartons labeled as amiodarone HCl injection, USP to contain vials of tranexamic acid injection, USP.
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The Protein Shoppe Red-E
The Protein Shoppe is voluntarily recalling all lots of Red-E male enhancement tablets, to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in an FDA-approved drug used in the treatment of erectile dysfunction. The presence of sildenafil in Red-E renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Learn more about the Protein Shoppe Red-E recall
RLC Labs Nature-Throid and WP Thyroid
RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid and WP Thyroid in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from six lots by the FDA found the samples to be sub potent.
Learn more about the RLC Labs Nature-Throid and WP Thyroid recall
SCA Compounded Heparin Products
SCA is voluntarily recalling 10 lots of heparin sodium injectable to the hospital/user level. The compounded heparin sodium bag contains the undeclared preservative benzyl alcohol. The labeling listed methylparaben and propylparaben as preservatives; however, they are not present in the product. SCA identified this labeling issue during the investigation of a low potency test result for heparin sodium (NDC 70004-0650-46).
Learn more about the SCA compounded heparin products recall
Atezolizumab with Paclitaxel for Treatment of Breast Cancer
The FDA is alerting healthcare professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer showed the drug combination did not work to treat the disease.
Learn more about atezolizumab with paclitaxel for treatment of breast cancer
Canagliflozin Amputation Boxed Warning Removed
Based on an FDA review of new data from three clinical trials, the agency has removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information.
Learn more about the FDA removing amputation boxed warning from canagliflozin
Emergency Use Authorization for Convalescent Plasma
The FDA sued an emergency use authorization for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.
Learn more about the emergency use authorization for convalescent plasma
FDA’s Do-Not-Use Hand Sanitizer List
The FDA recommends checking its do-not-use hand sanitizer list maintained online. The list is updated regularly as new test results are released. Recent notices include a warning about hand sanitizer packaged in food and drink containers and a testing method to assess the quality of hand sanitizer products for impurities.
Learn more about the FDA’s do-not-use hand sanitizer list
Mitigating Shortages of Rifampin and Rifapentine
The FDA recently became aware of nitrosamine impurities in certain samples of rifampin and rifapentine. Patients taking rifampin or rifapentine should continue taking their current medicine and consult with their healthcare professional about any concerns. To mitigate or avoid shortages and to help ensure patients have access to these necessary medicines, the FDA does not object to certain manufacturers temporarily distributing rifampin containing 1-methyl-4-nitrosopiperazine or rifapentine containing 1-cyclopentyl-4-nitrosopiperazine above the acceptable intake limits until they can reduce or eliminate the impurities.
Learn more about the FDA mitigating shortages of rifampin and rifapentine
Risks Associated with Intraocular use of Compounded Moxifloxacin
The FDA recommends that before healthcare professionals administer moxifloxacin intraocularly, they know its formulation. The agency also alerts compounders, ophthalmologists, and other healthcare professionals of risks associated with the intraocular administration of moxifloxacin drugs that contain more than 0.3mL of 0.5% moxifloxacin or that contain certain potentially harmful inactive ingredients, such as xanthan gum. Additionally, the FDA cautions healthcare professionals to carefully consider the concentration and inactive ingredients of any moxifloxacin drug before intraocular administration.
Learn more about risks associated with intraocular use of compounded moxifloxacin
Sale of Unapproved and Misbranded Opioids Online
The FDA has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act. Misbranded opioids include those offered for sale without a prescription, as well as opioids that lack adequate directions for use. The opioids offered for sale include products such as tramadol and oxycodone.
Learn more about the sale of unapproved and misbranded opioids online
Veklury Emergency Use Authorization Broadened
The FDA has broadened the scope of the existing emergency use authorization for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
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