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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Cytalux (pafolacianine) for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. Cytalux is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. Learn more about Cytalux


    The FDA has approved Fyarro (sirolimus) protein-bound particles for injectable suspension (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Fyarro is the first and only FDA-approved treatment for advanced malignant PEComa in adults. Learn more about Fyarro


    The FDA has approved Livtencity (maribavir) for the treatment of adults and pediatric patients (aged 12 years or older and weighing at least 35kg) with post-transplant cytomegalovirus infection/disease that is refractory to treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet. Learn more about Livtencity


    The FDA has approved Lyvispah (baclofen) oral granules for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Learn more about Lyvispah


    The FDA has approved Voxzogo (vosoritide) for injection, indicated to increase linear growth in pediatric patients with achondroplasia who are aged five and older with open epiphyses (growth plates). Voxzogo is the first FDA-approved treatment for children with achondroplasia. Learn more about Voxzogo

    FDA New Indications


    The FDA has approved expanded labeling for Caldolor (ibuprofen) to include use in preoperative administration. The non-narcotic pain reliever may now be administered just prior to surgery to enable patients to wake up from their procedure in significantly less pain. Learn more about Caldolor


    The FDA has approved Keytruda (pembrolizumab) for the adjuvant treatment of adult and pediatric (aged 12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (aged 12 years and older). Learn more about Keytruda

    FDA New Dosing


    The FDA has approved Tpoxx (tecovirimat) capsules for a new dosing regimen to treat smallpox disease in adult and pediatric patients weighing 120kg or more. Learn more about Tpoxx

    FDA New Combinations

    Darzalex Faspro with Kyprolis and Dexamethasone

    The FDA has approved Darzalex Faspro (daratumumab/hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. Learn more about Darzalex Faspro with Kyprolis and dexamethasone

    FDA Recalls

    American Screening Hand Sanitizer

    American Screening is voluntarily recalling 153,336 units of hand sanitizer containing 70% ethyl alcohol gel, to the consumer level. The hand sanitizer is packaged in 8-oz. containers that resemble water bottles, posing a risk of consumption. Learn more about the American Screening hand sanitizer recall

    Sagent Levetiracetam Injection

    Sagent Pharmaceuticals announced the voluntary nationwide recall of four lots of levetiracetam injection, USP, to the user level. The lack of container closure integrity found in reserve sample vials may result in a non-sterile product. Learn more about the Sagent levetiracetam injection recall

    Sandoz Enoxaparin Sodium Injection

    Sandoz is initiating a recall of one lot (SAB06761A, Exp 04/2023) of enoxaparin sodium injection, USP 40mg/0.4mL single-dose syringes, to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin sodium for injection lot SAB06761A was shipped to customers in the months of September and October 2021. Learn more about the Sandoz enoxaparin sodium injection recall