FDA New Approvals
FDA has approved Bylvay (odevixibat), the first drug approved for the treatment
of pruritus in all subtypes of progressive familial intrahepatic cholestasis.
Bylvay is a potent, non-systemic ileal bile acid transport inhibitor, which
does not require refrigeration and is easily administered as a once-daily
capsule or opened and sprinkled onto soft foods.
Learn more about Bylvay
The FDA has approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
Learn more about Kerendia
The FDA has approved Rezurock (belumosudil) 200mg once daily for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy.
Learn more about Rezurock
The FDA has approved Saphnelo (anifrolumab-fnia) for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. This marks the first regulatory approval for a type I interferon receptor antagonist and the only new treatment approved for SLE in more than 10 years.
Learn more about Saphnelo
The FDA has approved Semglee (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway. The interchangeable Semglee product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be introduced before the end of the year.
Learn more about Semglee
The FDA has approved Twyneo (benzoyl peroxide/tretinoin) cream, 3%/0.1%, indicated for the treatment of acne vulgaris in adults and pediatric patients aged 9 years and older. Twyneo uses patented technology to entrap tretinoin, a retinoid, and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to slowly release each of the active drug ingredients over time to provide a favorable efficacy and safety profile.
Learn more about Twyneo
The FDA has approved Vaxneuvance (pneumococcal 15-valent conjugate
vaccine) for active immunization for the prevention of invasive disease caused
pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,
22F, 23F, and 33F in adults aged 18 years and older.
Learn more about Vaxneuvance
FDA New Indications
Bydureon and Bydureon BCise
The FDA has approved Bydureon and Bydureon BCise (exenatide extended-release) injection to be used in addition to diet and exercise to improve glycemic control (blood sugar levels) in pediatric patients aged 10 years or older with type 2 diabetes. Exenatide extended-release was previously approved to treat adults with type 2 diabetes.
Learn more about Bydureon and Bydureon BCise
The FDA has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients aged 18 years and older with inadequate response to nasal corticosteroids.
Learn more about Nucala
The FDA has granted Padcev (enfortumab vedotin-ejfv) regular approval in the US, in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Cisplatin-ineligible patients typically have limited treatment options and a poor prognosis.
Learn more about Padcev
The FDA has approved the supplemental new drug application for Prograf (tacrolimus) for use in combination with other immunosuppressant drugs for the prevention of organ rejection in adult and pediatric lung transplant recipients.
Learn more about Prograf
The FDA has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals.
Learn more about Shingrix
FDA New Dosing
The FDA has approved Uptravi (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class II–III, who are temporarily unable to take oral therapy. Uptravi IV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on Uptravi therapy, as uninterrupted treatment is considered key for individuals with PAH. Uptravi tablets were first approved by the FDA in 2015 to delay disease progression and reduce the risk of hospitalization for PAH.
Learn more about Uptravi
FDA New Combinations
Darzalex Faspro in Combination with Pomalidomide and Dexamethasone
The FDA has approved Darzalex Faspro (daratumumab/hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for Darzalex Faspro in the treatment of multiple myeloma.
Learn more about Darzalex Faspro in combination with pomalidomide and dexamethasone
Keytruda in Combination with Chemotherapy
The FDA has approved Keytruda (pembrolizumab) for the treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.
Learn more about Keytruda in combination with chemotherapy
Keytruda Plus Lenvima
The FDA has approved the combination of the anti-PD-1 therapy Keytruda (pembrolizumab) plus Lenvima (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Learn more about Keytruda plus Lenvima
Alpha Male Plus Male Enhancer Fruit Chew
Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Learn more about the Alpha Male Plus Male Enhancer fruit chew recall
HIS Miss Slim
HIS is voluntarily recalling all lots and all presentations of Miss Slim (10-count and 30-count capsules) to the consumer level. HIS decided to recall Miss Slim after the FDA contacted it regarding the presence of sibutramine in the product.
Learn more about the HIS Miss Slim recall
Innoveix Sterile Compounded Drug Products
Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots of sterile compounded drug products, within expiry. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by the FDA.
Learn more about the Innoveix sterile compounded drug products recall
Johnson & Johnson Sunscreen Products
Johnson & Johnson Consumer Inc. is voluntarily recalling all lots of five Neutrogena and Aveeno aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products.
Learn more about the Johnson & Johnson sunscreen products recall
Pfizer Chantix Tablets
Pfizer is voluntarily recalling two lots of Chantix 0.5mg tablets, two lots of Chantix 1mg tablets, and eight lots of a Chantix kit of 0.5mg/1mg tablets to the consumer level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer-established acceptable daily intake level.
Learn more about the Chantix recall
Amgen Misbranding Neulasta
The FDA has issued an untitled letter to Amgen Inc. for the misbranding of its biological product, Neulasta (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication. Amgen Inc. released a promotional communication that makes false or misleading claims and representations about the benefit of Neulasta when administered through the Onpro on-body injector compared to a prefilled syringe. Neulasta is the reference product for all FDA-licensed biosimilar pegfilgrastim products, which are only available as a prefilled syringe.
Learn more about Amgen misbranding Neulasta
The FDA is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. The FDA has conducted a comprehensive review of all available data and is requesting that statin manufacturers make this change to the prescribing information as part of the FDA’s ongoing effort to update the pregnancy and breastfeeding information for all prescription medicines.
Learn more about the FDA’s cholesterol-lowering statins Drug Safety Communication
Clozapine REMS Update
The FDA has approved a modification to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program. Beginning November 15, 2021, significant requirements for healthcare professionals will go into effect.
Learn more about the Clozapine REMS update
The FDA is alerting patients and healthcare professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death.
Learn more about the Pepaxto alert