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  • FDA Drug Updates

    FDA New Approvals

    Arikayce

    The FDA approved Arikayce (amikacin liposome inhalation suspension) for the treatment of lung disease caused by Mycobacterium avium complex in a limited population of patients with the disease who do not respond to conventional treatment. Learn more about Arikayce

    Copiktra

    The FDA granted regular approval to Copiktra (duvelisib) for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies. In addition, Copiktra received accelerated approval for adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. Learn more about Copiktra

    Emgality

    The FDA approved Emgality (galcanezumab-gnlm) for the preventative treatment of migraine in adults. Emgality offers a once-monthly, self-administered, 120mg subcutaneous injection. Learn more about Emgality

    Libtayo

    The FDA approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC. Learn more about Libtayo

    Nuzyra

    The FDA has approved Nuzyra (omadacycline) for treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infection. Nuzyra is a modernized tetracycline with broad-spectrum activity that is designed to overcome tetracycline resistance. Learn more about Nuzyra

    Revcovi

    The FDA has granted approval to Revcovi (elapegademase-lvlr) injection. Revcovi is a new enzyme replacement therapy for the treatment of adenosine deaminase severe combined immune deficiency in pediatric and adult patients. Learn more about Revcovi

    Seysara

    The FDA has approved Seysara (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Seysara is a once-daily oral tablet with anti-inflammatory properties that can be taken with or without food. Learn more about Seysara

    Talzenna

    The FDA approved Talzenna (talazoparib), a poly (ADP-ribose) polymerase inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib. Learn more about Talzenna

    Tegsedi

    The FDA approved Tegsedi (inotersen), an antisense oligonucleotide that inhibits the production of the transthyretin amyloid protein, for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Learn more about Tegsedi

    Vizimpro

    The FDA approved Vizimpro (dacomitinib) tablets for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Learn more about Vizimpro

    Xelpros

    The FDA has approved Xelpros (latanoprost) 0.005% ophthalmic emulsion for reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Xelpros is the first and only form of latanoprost that is not formulated with benzalkonium chloride, a preservative commonly used in topical ocular preparations. Learn more about Xelpros

    Xyosted

    The FDA approved Xyosted (testosterone enanthate) subcutaneous injection for testosterone replacement therapy in men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone. Xyosted is the first FDA-approved subcutaneous testosterone enanthate product for once-weekly self-administration using a disposable autoinjector. The FDA approved the product in three dosage strengths: 50mg, 75mg, and 100mg. Learn more about Xyosted

    Yutiq

    The FDA has approved Yutiq (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Yutiq is a non-bioerodible intravitreal micro-insert in a drug delivery system containing 0.18mg fluocinolone acetonide, designed to release consistently over 36 months. Yutiq is supplied in a sterile single-dose preloaded applicator that can be administered in the physician’s office. Learn more about Yutiq

    FDA New Dosing

    Kyprolis

    The FDA has approved the supplemental new drug application to expand the prescribing information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma. Learn more about Kyprolis

    FDA New Indications

    Fycompa

    The FDA has approved indication expansion for the antiepileptic drug Fycompa (perampanel) to cover partial-onset seizures in pediatric patients with epilepsy 4 years of age and older. Learn more about Fycompa

    Gardasil 9

    The FDA has approved a supplemental application for Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) to include women and men aged 27 through 45 years. Learn more about Gardasil 9

    Hemlibra

    The FDA approved Hemlibra (emicizumab-kxwh) injection for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (ages newborn and older) with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. Learn more about Hemlibra

    Xarelto

    The FDA has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction, and stroke, in people with chronic coronary or peripheral artery disease. Xarelto is now the first and only Factor Xa inhibitor approved for patients living with these conditions. Learn more about Xarelto

    FDA Recalls

    Endo Pharmaceuticals Robaxin 750mg Tablets

    Endo Pharmaceuticals is voluntarily recalling two lots of Robaxin (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." Learn more about the Endo Pharmaceuticals Robaxin recall

    Fat Burners Zone Zero Xtreme Capsules

    Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine, an appetite suppressant that was withdrawn from the US market due to safety concerns. Learn more about the Fat Burners Zone Zero Xtreme capsules recall

    Liveyon ReGen Series Product

    Liveyon is a distributor of stem cell products manufactured by Genetech. Liveyon marketed and distributed these products under the trade name ReGen Series. Liveyon has voluntarily recalled all ReGen Series products due to reported possible adverse reactions. Learn more about the Liveyon ReGen Series product recall

    Pharm D Solutions Sterile Compounded Drugs

    Pharm D Solutions is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician, or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by the FDA. Learn more about the Pharm D Solutions sterile compounded drugs recall

    Silver Star Brands Products

    Silver Star Brands is initiating a voluntary recall of six products for humans including four Native Remedies, two Healthful Naturals, and two PetAlive products for pets, for a total of eight. The products have been tested and found to contain microbial contamination. Learn more about the Silver Star Brands product recall

    Sprayology Homeopathic Aqueous-Based Medications

    Sprayology is voluntarily recalling all lots within expiry from 10/2018 to 7/2022 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination. Learn more about the Sprayology homeopathic aqueous-based medication recall

    FDA Alerts

    Caution When Using Pen Needles to Inject Medications

    The FDA is reminding patients, caregivers, and healthcare providers of the importance of knowing how to use their pen needles correctly and the potential risks if the standard pen needle’s inner needle’s cover is not removed prior to injection. Learn more about using caution when using pen needles to inject medications

    Epidiolex DEA Rescheduling

    The DEA has rescheduled the epilepsy drug Epidiolex (cannabidiol) from Schedule I to Schedule V, the classification with the lowest degree of restriction. The FDA approved Epidiolex in June for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older. Learn more about the DEA rescheduling of Epidiolex

    Nuplazid: No New Safety Risks

    The FDA has completed a review of all postmarketing reports of deaths and serious adverse events reported with the use of Nuplazid (pimavanserin). Based on an analysis of all available data, the FDA did not identify any new or unexpected safety findings with Nuplazid, or findings that are inconsistent with the established safety profile currently described in the drug label. After a thorough review, the FDA’s conclusion remains unchanged that the drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis. Learn more about FDA analysis of safety risks of Nuplazid

    Valsartan Products Recall Update

    The FDA’s latest testing of valsartan products shows an additional unexpected impurity in three lots of Torrent Pharmaceuticals’ recalled valsartan drug products. This second impurity, N-Nitrosodiethylamine (NDEA) is a known animal and suspected human carcinogen. These Torrent products were included in the company’s recall in August 2018. The FDA is continuing to test all products that contain valsartan for NDEA and related impurities. If the agency finds NDEA in products that have not been recalled, the FDA will work with companies to ensure all affected products are removed from the market. The agency is also evaluating the risks NDEA in these products poses to patients. Learn more about the update on recalled valsartan products