FDA New Approvals
The FDA has approved Aristada Initio (aripiprazole lauroxil) a new, smaller particle-size version of extended-release injectable Aristada for adults with schizophrenia. Combining the new product with a single 30mg dose of oral aripiprazole provides physicians with an alternative regimen to initiate patients onto any dose of Aristada on day one.
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Braftovi and Mektovi
The FDA approved Braftovi (encorafenib) and Mektovi (binimetinib) individually with the indication to be used in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. The recommended doses are Mektovi 45mg orally twice daily and Braftovi 450mg orally once daily.
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The FDA approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
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The FDA has approved Infugem (gemcitabine in 0.9% sodium chloride injection) 10mg/mL, for intravenous use in a ready-to-administer (RTA) bag. Infugem uses a proprietary technology which allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in RTA infusion bags. It involves dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for ranges (or “bands”) of doses calculated for individual patients. The RTA bags will provide greater safety by preventing problems of over or under-dosing, preventing the risk of contamination that can lead to infections, and by taking care of problems associated with, and precautions to be taken while, handling cytotoxic drugs by healthcare providers.
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The FDA approved Kisqali (ribociclib) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer. Kisqali is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women in the US, and also is indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women.
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The FDA has approved, under Priority Review,
single-dose Krintafel (tafenoquine) for the radical cure (prevention of
relapse) of Plasmodium vivax malaria in patients aged 16
years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. Krintafel
is an 8-aminoquinoline derivative with activity against all stages of the P. vivax lifecycle,
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The FDA has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product. Nivestym is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia; to reduce the duration of neutropenia and neutropenia-related clinical sequelae in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and for chronic administration to reduce the incidence and duration of sequelae of severe neutropenia in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
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The FDA approved Orilissa (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. The FDA approved Orilissa under priority review. Orilissa represents the first FDA-approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a decade and is expected to be available in US retail pharmacies in early August 2018.
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The FDA has approved topical Qbrexza (glycopyrronium) for the treatment of adults and children as young as age 9 years who have primary axillary hyperhidrosis. Qbrexza is a topical anticholinergic cloth applied to the underarms and designed to block sweat production by inhibiting sweat gland activation.
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The FDA has approved Symtuza (darunavir 800mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg), the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. Symtuza combines the proven high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of an STR. Symtuza has a Boxed Warning regarding the risk of post-treatment acute exacerbation of hepatitis B.
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The FDA granted approval of Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. Tibsovo, an oral, targeted inhibitor of the IDH1 enzyme, is the first and only FDA-approved therapy for patients with R/R AML and an IDH1 mutation.
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The FDA has approved Tpoxx (tecovirimat), the first drug with an indication for treatment of smallpox. Tpoxx is the first product to be awarded a material threat medical countermeasure priority review voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiologic, and nuclear threats.
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Yervoy and Opdivo
The FDA granted accelerated approval to Yervoy (ipilimumab) for use in combination with Opdivo (nivolumab) for the treatment of patients 12 years of age and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This new use has also been added to the Opdivo labeling. Nivolumab received accelerated approval for this indication as a single agent on July 31, 2017. The recommended dosage regimen for this indication is nivolumab 3mg/kg IV followed by ipilimumab 1mg/kg every 3 weeks for 4 doses, then nivolumab 240mg every 2 weeks.
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The FDA approved the antibiotic Zemdri (plazomicin) to treat adults with complicated
urinary tract infections, including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae,
Proteus mirabilis, or Enterobacter
cloacae, in patients who have limited or no alternative treatment
options. Zemdri is an intravenous infusion, administered once daily.
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FDA New Indications
The FDA has approved updated labeling for Intelence (etravirine) to include treatment-experienced pediatric patients 2 years to less than 6 years of age weighing at least 10kg for the treatment of HIV-1 infection, in combination with other antiretrovirals. Previously, this antiretroviral agent was approved only for patients ≥6 years of age.
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The FDA has approved the supplemental Biologics License Application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. Xeomin is the first and only neurotoxin with this approved indication in the US. This is the fourth neurological indication for Xeomin, which was first approved by the FDA in 2010 for the treatment of cervical dystonia and blepharospasm (in patients previously treated with onabotulinumtoxinA) in adult patients and later in 2015 for upper limb spasticity in adult patients.
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The FDA has approved Xtandi (enzalutamide) for the treatment of men with castration-resistant prostate cancer (CRPC). The approval extends the indication for the oral therapy, which was previously approved for men with metastatic CRPC.
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Blissful Remedies Kratom Powder Capsule
Blissful Remedies is voluntarily recalling only Lot No.:
112710 with expiration 03/2019 found embedded on the top of package of kratom
powder capsule products, it manufactured, processed, packed, and/or held,
between March 1, 2018 to April 30, 2018 to the consumer level due to Salmonella contamination.
Learn more about the Blissful Remedies kratom powder capsule recall
Fagron Sterile Services Neostigmine Methylsulfate
Fagron Sterile Services is voluntarily recalling two lots of neostigmine methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing neostigmine methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as neostigmine methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as neostigmine methylsulfate 1mg/mL, 5mg per 5mL.
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Gaia Ethnobotanical, LLC Kratom Powder Products
Gaia Ethnobotanical, LLC., is voluntarily
recalling all kratom powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The
products have been found by the FDA via sample testing to have Salmonella contamination. In lieu of such FDA findings the
company has implemented standard operating procedures and sterilization
processes in accordance to FDA guidelines.
Learn more about the Gaia Ethnobotanical, LLC kratom powder products recall
King Bio Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids
King Bio is
voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox,
and Baby Teething liquids to the consumer level. During a routine inspection by
the FDA, the products were found to
contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens, and Burkholderia Multivorans.
Administration or use of drug products with microbial contamination could
potentially result in increased infections that may require medical
intervention and could result in infections
that could be life threatening to certain individuals. King Bio has not received
reports of injury or illness.
Learn more about the King Bio recall
LL's Magnetic Clay, Inc. Prescript-Assist
LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. All lots sold between 1/29/2015 through 12/31/2017 are potentially impacted. The white bottles contain capsules in quantities of either 60 or 90 capsules per bottle.
Learn more about the LL’s Magnetic Clay, Inc. Prescript-Assist recall
The FDA is recalling several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
Learn more about the valsartan products recall
Fake FDA Warning Letters
The FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone. Based on the agency’s experience with criminals posing as FDA employees, the FDA is concerned that these fake warning letters are linked to an international extortion scam. The FDA generally does not issue warning letters to individuals who purchase medicines online.
Learn more about fake FDA warning letters
Fluoroquinolone Antibiotics Stronger Labeling Warnings
The FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. The changes will add that hypoglycemia can lead to coma, and the new label will also make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.
Learn more about fluoroquinolone antibiotic labeling changes
The FDA advises healthcare professionals not to use any Monsel’s Solution (ferric subsulfate 20%) because the drug product was made under poor conditions. The solution is manufactured by BioDiagnostics International and distributed by MedGyn Products, Inc. BioDiagnostics notified MedGyn of the recall of all lots of Monsel’s Solution on June 11, 2018. However, MedGyn has not yet notified its customers to remove any distributed drug product from the market.
Learn more about Monsel’s Solution
Ranier’s Compounding Laboratory Sterile Products
The FDA is alerting healthcare professionals and patients, as well as veterinarians and animal owners, not to use human and animal drug products intended to be sterile that are produced and distributed by Ranier’s Compounding Laboratory, also doing business as Ranier’s Pharmacy and Ranier’s RX Laboratory, due to lack of sterility assurance.
Learn more about Ranier’s Compounding Laboratory sterile products