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  • FDA Drug Updates

    FDA New Approvals

    Aklief

    The FDA has now approved Aklief (trifarotene) cream, 0.005% for the topical treatment of acne. Aklief cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. Learn more about Aklief

    Beovu

    The FDA has approved Beovu (brolucizumab-dbll) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is administered by intravitreal injection. The recommended dose for Beovu is 6mg monthly for the first three doses, followed by one dose of 6mg every 8-12 weeks. Learn more about Beovu

    Darzalex Combination Regimen

    The FDA approved Darzalex (daratumumab) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. The recommended dose of Darzalex is 16mg/kg of actual body weight. Learn more about Darzalex combination regimen

    Jynneos

    The FDA has announced the approval of Jynneos (smallpox and monkeypox vaccine, live, non-replicating), for the prevention of smallpox and monkeypox disease in adults aged 18 years and older who are determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease. Learn more about Jynneos

    Rybelsus

    The FDA approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the US that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes. Rybelsus should be taken at least 30 minutes before the first food, beverage, or other oral medication of the day, with no more than 4 oz of plain water. Learn more about Rybelsus

    Scenesse

    The FDA has granted marketing approval to use Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria patients. Scenesse acts as a potent anti-oxidative and melanogenic agent providing pandermal (total surface) photoprotection. Learn more about Scenesse

    FDA New Indications

    Delstrigo

    The FDA approved an update to Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) product labeling to expand the indication to include patients 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 Delstrigo. Learn more about Delstrigo

    Descovy

    The FDA has approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg tablets; F/TAF). Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35kg who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex. Learn more about Descovy

    Entresto

    The FDA has approved Entresto (sacubitril/valsartan) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in children aged 1 year and older. Learn more about Entresto

    Erleada

    The FDA approved Erleada (apalutamide) for patients with metastatic castration-sensitive prostate cancer. Erleada is taken orally, once daily, with or without food. Erleada was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer. Learn more about Erleada

    Invokana

    The FDA has approved Invokana (canagliflozin) to reduce the risk of end-stage kidney disease, worsening of kidney function, cardiovascular death, and heart failure hospitalization, in adults with type 2 diabetes and diabetic kidney disease. Learn more about Invokana

    Keytruda Plus Lenvima

    The FDA granted accelerated approval to the combination of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. Learn more about Keytruda plus Lenvima

    Mavyret

    The FDA expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children aged 12 years and older or weighing at least 99 lbs who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve). Learn more about Mavyret

    Pifeltro

    The FDA approved an update for Pifeltro (doravirine) product labeling to expand the indication to include patients 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 doravirine. Pifeltro is a non-nucleoside reverse transcriptase inhibitor to be administered in combination with other antiretroviral agents. Learn more about Pifeltro

    Rituxan

    The FDA approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis and microscopic polyangiitis in children aged 2 years and older in combination with glucocorticoids (steroid hormones). It is the first approved treatment for children with these rare vasculitis diseases. Learn more about Rituxan

    Tybost

    The FDA approved changes to Tybost (cobicistat) tablet labeling to expand the patient population for Tybost coadministered with darunavir to include pediatric patients with HIV-1 infection weighing at least 40kg. Tybost is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once-daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in pediatric patients. Learn more about Tybost

    FDA Recalls

    Apotex Ranitidine

    Apotex is voluntarily, on a precautionary basis, recalling ranitidine tablets 75mg and 150mg (all pack sizes and formats) to the retail level. Apotex has learned from the FDA and other global regulators that some ranitidine medicines, including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine at low levels. Learn more about the Apotex ranitidine recall

    Cellect and Oglethorpe Products

    Cellect and Oglethorpe are voluntarily recalling lot #041907 of Cellect Unflavored Powder and Essentials Factor Cell Synergy Unflavored Powder (1.25 lb) to the retail and consumer level. The Cellect Unflavored Powder and Essentials Factor Cell Synergy Unflavored Powder have been found to have unsafe levels of arsenic and lead. Learn more about the Cellect and Oglethorpe products recall

    Darmerica Quinacrine Dihydrochloride

    Darmerica is voluntarily recalling two lots, DR4654A and DL4654A (expiration date of April 27, 2021), of quinacrine dihydrochloride, bulk API powder packaged in amber HDPE bottles, to the consumer level. Quinacrine dihydrochloride was distributed nationwide to 14 compounding pharmacies. This product is being recalled due to a label mix-up. Product intended for further compounding use by pharmacies labeled as quinacrine API was tested and identified as artemisinin API. Learn more about the Darmerica quinacrine dihydrochloride recall

    Fitoterapia Liquid Supplement

    Fitoterapia is voluntarily recalling Mero Macho artificial passion fruit flavored vitamin C liquid supplement to the consumer level. FDA analysis has found the product to be tainted with tadalafil. The presence of tadalafil in Mero Macho renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Learn more about the Fitoterapia liquid supplement recall

    Mavidon LemonPrep

    Mavidon is voluntarily recalling 21 lots of LemonPrep 4 oz tubes and single-use cups, to the user level. These products have been found to be contaminated with Burkholderia cepacia. LemonPrep is used as abrasive skin prepping lotion and designed to lower skin impedance and enhance the signal quality at the electrode site. Learn more about the Mavidon LemonPrep recall

    Sandoz Ranitidine HCl

    Sandoz is voluntarily recalling all quantities and lots within expiry of ranitidine HCl capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine above levels established by the FDA. Learn more about the Sandoz ranitidine HCl recall

    Takeda Natpara

    Takeda issued a recall for all doses of Natpara (parathyroid hormone) for injection (25mcg, 50mcg, 75mcg, and 100mcg). This recall is being conducted after discussions with the FDA and is effective immediately due to a potential issue related to rubber particulates originating from the rubber septum of the Natpara cartridge. During the 14-day Natpara treatment period, the septum is punctured by a needle each day to obtain the daily dosage of Natpara solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge. Consistent with the product labeling, Takeda is alerting Natpara patients and prescribers that discontinuing Natpara abruptly can cause a severe hypocalcemia, which can result in serious health consequences. Learn more about the Takeda Natpara recall

    Torrent Losartan Potassium and Losartan Potassium/HCTZ

    Torrent is expanding its voluntary recall to include five additional lots of losartan potassium tablets (three lots of losartan potassium tablets and two lots of losartan potassium/HCTZ combination tablets). This recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan API manufactured by Hetero Labs. Torrent is recalling lots of losartan-containing medication that tested positive for NMBA above 9.82 ppm. Learn more about the Torrent losartan potassium and losartan potassium/HCTZ recall

    FDA Alerts

    LOBO Contains Hidden Ingredients

    The FDA is advising consumers not to purchase or use LOBO, a product promoted for sexual enhancement. FDA laboratory analysis confirmed that LOBO contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction. Learn more about LOBO containing hidden ingredients

    Loperamide New Packaging

    The FDA announced approved package size and package type limits for OTC brand-name tablet and capsule forms of loperamide. The changes to Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl capsules are intended to address the problem of loperamide abuse and misuse by limiting each carton to no more than 48mg of loperamide and requiring unit-dose blister packaging. Learn more about loperamide new packaging

    Love in S Contains Hidden Ingredients

    The FDA is advising consumers not to purchase or use Love in S, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that Love in S contains sibutramine and N-desmethylsibutramine. N-desmethylsibutramine is structurally similar to sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and/or heart rate in some people and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Learn more about Love in S containing hidden ingredients

    NDMA Found in Samples of Some Ranitidine Medicines

    The FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their healthcare professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. Learn more about NDMA being found in samples of some ranitidine medicines

    Sheaya Lender Contains Hidden Ingredients

    The FDA is advising consumers not to purchase or use Sheaya Lender, a product promoted for weight loss. FDA laboratory analysis confirmed that Sheaya Lender contains sibutramine and fluoxetine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Fluoxetine is an FDA-approved drug in a class of drugs called selective serotonin reuptake inhibitors used for treating depression, bulimia, obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder. Learn more about Sheaya Lender containing hidden ingredients