FDA New Approvals
Artesunate for Injection
The FDA has approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with IV artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen. Prior to this approval, IV artesunate was only available to patients through the FDA's Expanded Access program.
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The FDA has approved Cerianna (fluoroestradiol F 18) injection for intravenous use. Cerianna is a molecular imaging agent indicated for use in positron emission tomography imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Cerianna is the first FDA-approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer.
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The FDA has approved Kynmobi (apomorphine HCI) sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). Kynmobi is the first and only sublingual therapy approved for the on-demand treatment of PD OFF episodes.
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The FDA has now approved Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months. Oriahnn is the first FDA-approved non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
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The FDA has approved Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Phexxi is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5, which is an acidic environment that is inhospitable to sperm.
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The FDA has approved Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Qinlock targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST.
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The FDA has granted accelerated approval to Rubraca (rucaparib) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and taxane-based chemotherapy.
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The radioactive diagnostic agent Tauvid (flortaucipir F 18 injection) has been approved by the FDA for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease. Tauvid is the first and only currently approved diagnostic agent to image tau NFTs in the brain.
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The FDA has now approved VESIcare LS (solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older. It is used to increase the amount of urine your bladder can hold and reduce urine leakage. VESIcare LS oral suspension will come in a 5mg/5mL (1mg/mL) oral suspension.
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FDA New Indications
The FDA approved Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test. This approval expands Alunbrig's current indication to include the first-line setting.
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The FDA has approved Brilinta (ticagrelor) for use with aspirin to cut the risk for a first myocardial infarction (MI) or stroke in high-risk patients with coronary artery disease but no history of MI or stroke. This is the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high cardiovascular risk, but without a history of heart attack or stroke.
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The FDA has approved Cyramza (ramucirumab injection, 10mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) mutations. With this approval, Cyramza has now received six FDA approvals to treat certain types of lung, liver, stomach, and colorectal cancers.
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The FDA has approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is currently the only biologic medicine approved for this population.
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Lynparza (olaparib) has been approved by the FDA for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The full indication is for the treatment of adult patients with deleterious or suspected deleterious germline or somatic HRR gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone. Patients are to be selected for treatment based on an FDA-approved companion diagnostic test for Lynparza.
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Opdivo and Yervoy
Opdivo (nivolumab) 360mg plus Yervoy (ipilimumab) 1mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the FDA for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.
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The FDA has now approved Pomalyst (pomalidomide) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients with Kaposi sarcoma who are HIV-negative.
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The FDA has approved a supplemental New Drug Application for Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of patients aged 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by certain susceptible Gram-negative microorganisms. Recarbrio is also indicated in adults who have limited or no alternative treatment options for complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections caused by susceptible Gram-negative bacteria. Recarbrio is administered via intravenous injection.
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The FDA has approved a supplemental Biologics License Application for Taltz (ixekizumab) injection 80mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. The approval makes Taltz the first IL-17A antagonist to be approved by the FDA for nr-axSpA. This is the fifth approval for Taltz.
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The FDA has approved Tecentriq (atezolizumab) as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression, as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. This is Tecentriq's fourth indication in metastatic NSCLC and fifth indication in lung cancer overall.
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Tecentriq and Avastin
The FDA has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
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The FDA has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
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Acella Pharmaceuticals NP Thyroid
Acella Pharmaceuticals is voluntarily recalling a total of 13 lots of 30mg, 60mg, and 90mg NP Thyroid (thyroid tablets, USP) to the consumer level. The products are being recalled because testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of liothyronine (T3).
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Amneal Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets
Amneal Pharmaceuticals is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP 500mg and 750mg, within expiry to the retail level. Amneal was notified by the FDA that the agency's testing of seven lots of metformin hydrochloride extended-release tablets, USP 500mg and 750mg, showed N-Nitrosodimethylamine amounts above acceptable FDA levels. The FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of metformin hydrochloride extended-release tablets, USP 500mg and 750mg, out of an abundance of caution.
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Apotex Corp. Metformin Hydrochloride Extended-Release Tablets
Apotex Corp is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP 500mg within expiry to retail level. Apotex was notified by the FDA that one lot of metformin hydrochloride extended-release tablets, USP was tested and showed results for N-Nitrosodimethylamine levels in excess of the Acceptable Daily Intake Limit and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of metformin hydrochloride extended-release tablets in the US.
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Biota Biosciences Cannabidiol Products
Biota Biosciences is voluntarily recalling multiple lots of Cannabidiol Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level. These injectable products are being recalled because they were marketed without FDA approval. The product claims on the Biota website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.
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Marksans Pharma Limited Metformin Hydrochloride Extended-Release Tablets
Marksans Pharma Limited, India is voluntarily recalling metformin hydrochloride extended-release tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine levels in excess of the Acceptable Daily Intake Limit.
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MasterPharm Finasteride Plus
MasterPharm is voluntarily recalling 1 lot of Finasteride Plus 1.25mg capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil was found when tested with an independent testing laboratory.
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Summitt Labs Kore Organic Watermelon CBD Oil
Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of Kore Organic Watermelon CBD Oil Tincture, 30mL bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation.
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Teva Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets
Teva Pharmaceuticals is voluntarily recalling fourteen lots of metformin hydrochloride extended-release tablets, USP 500mg and 750mg, 100 and 1000 count bottles, in the US to the consumer-level due to the detection of N-Nitrosodimethylamine levels in excess of the Acceptable Daily Intake Limit.
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Absence of Warning Statement on the Vial Caps of Two Neuromuscular Blocking Agents
The FDA is notifying healthcare professionals about the temporary absence of the "paralyzing agent" warning statement embossed on the vial caps of two neuromuscular blocking agents. Vecuronium bromide for injection 10mg per vial and 20mg per vial and rocuronium bromide injection 50mg/5mL, 100mg/10mL, commonly used to provide muscle relaxation during surgery or mechanical ventilation, usually include a warning statement embossed on the vial cap to identify the product as a paralyzing agent. Careful handling of these neuromuscular blocking agents is vital to prevent medication errors that could result in serious harm or death.
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Amneal and Impax Laboratories Epinephrine Auto-injector Device Malfunctions
The FDA is alerting patients, caregivers, and healthcare professionals to inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3mg to ensure the yellow "stop collar" in the device is present. Certain lots of these devices might not contain the yellow "stop collar" component. If the auto-injector is missing the component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient.
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Emergency Use Authorization for Fresenius Propoven 2% Emulsion
The FDA issued an Emergency Use Authorization (EUA) for Fresenius Propoven 2% Emulsion to maintain sedation via continuous infusion in patients aged 16 years or older who require mechanical ventilation in an ICU during the COVID-19 public health emergency. Fresenius Propoven 2% Emulsion has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet for more information before administering it.
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Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products
The FDA announced that agency laboratory testing revealed levels of the nitrosamine impurity N-Nitrosodimethylamine above the agency's acceptable intake limit in several lots of the extended-release formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. The agency is in contact with five firms to recommend they voluntarily recall their products. Company recall notices will be posted on the FDA's website.
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Serious Mental Side Effects with Montelukast
The FDA has approved safety labeling changes for Singulair (montelukast) and generics, a prescription medicine for asthma and allergies, to enhance patients/caregivers and healthcare professional's awareness of potential mental health side effects. The FDA is strengthening existing warnings about the side effects by requiring a Boxed Warning to be added to the prescribing information and a medication guide for patients.
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