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  • FDA Drug Updates

    FDA New Approvals


    The FDA approved Crysvita (burosumab-twza) for the treatment of X-linked hypophosphatemia in adult and pediatric patients one year of age and older. Crysvita is an antibody that blocks fibroblast growth factor 23 (FGF23), a hormone that causes phosphate urinary excretion and suppresses active vitamin D production by the kidney. Learn more about Crysvita


    The FDA has approved Ilumya (tildrakizumab-asmn) for adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy. Ilumya is a selective interleukin-23p19 inhibitor given by 100mg subcutaneous injection every 12 weeks, after the completion of initial doses at week 0 and week 4. Learn more about Ilumya


    The FDA approved Rubraca (rucaparib) a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The recommended rucaparib dose is 600mg (two 300mg tablets) taken orally twice daily with or without food. Learn more about Rubraca

    Toujeo Max SoloStar

    The FDA has approved Toujeo (insulin glargine 300 units/mL) Max SoloStar. The new Max SoloStar pen holds 900 units of Toujeo and provides up to 160 units/mL of Toujeo in a single injection. Toujeo Max SoloStar will launch in retail pharmacies across the US in Q3 2018. Learn more about Toujeo Max SoloStar

    FDA New Indications


    The FDA approved Adcetris (brentuximab vedotin) in combination with chemotherapy in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma. The approval was based on the successful outcome of the phase 3 ECHELON-1 clinical trial that compared Adcetris plus AVD (Adriamycin, vinblastine and dacarbazine) to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine). In addition, data from the ECHELON-1 trial converted the US accelerated approval of Adcetris for the treatment of adults with systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimen to regular approval. In October 2017, the FDA granted breakthrough therapy designation to Adcetris in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA also granted priority review for the supplemental biologics license application, and the Prescription Drug User Fee Act target action date was May 1, 2018. Learn more about Adcetris

    Afinitor Disperz

    The FDA has approved Afinitor Disperz (everolimus) tablets for oral suspension for the adjunctive treatment of adults and children aged 2 years and older with tuberous sclerosis complex-associated partial-onset seizures. Afinitor Disperz is now the first approved pharmacologic therapy in the US specifically indicated for the treatment of this condition. Learn more about Afinitor Disperz


    The FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse. The FDA first approved Blincyto under accelerated approval in December 2014 for the treatment of Philadelphia chromosome-negative relapsed or refractory positive B-cell precursor ALL. Learn more about Blincyto


    The FDA has approved a supplemental new drug application for Exparel (bupivacaine liposomal) injectable suspension for use as an interscalene brachial plexus nerve block to provide regional analgesia following shoulder surgery in adults. In 2011, Exparel was approved for local administration to provide post-surgical analgesia. Learn more about Exparel


    The FDA approved a new indication for Leukine (sargramostim) to increase survival of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS) as could occur after a radiological or nuclear event. Leukine is the third FDA-approved medical countermeasure that is indicated to increase survival in patients exposed to myelosuppressive doses of radiation. Learn more about Leukine


    The FDA has approved a four-week dosing schedule for Opdivo (nivolumab). Opdivo with a two-week dosing schedule was previously approved to treat a number of cancers such as melanoma. The drug was also approved for shorter 30-minute infusions, reducing previous infusion time in half. Learn more about Opdivo


    The FDA converted the accelerated approval for Praxbind (idarucizumab), granted in October 2015, to full approval. Praxbind is the specific reversal agent for Pradaxa (dabigatran etexilate mesylate). Praxbind is indicated for patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. Learn more about Praxbind


    The FDA expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). In the US, Tasigna is now indicated for the treatment of adult and pediatric patients one year of age or older with newly diagnosed Ph+ CML-CP. Tasigna is also indicated for the treatment of pediatric patients one year of age or older with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor therapy, as well as adult patients with Ph+ CML in chronic phase and accelerated phase, resistant or intolerant to prior therapy that included imatinib. Learn more about Tasigna

    FDA Recalls

    AdvoCare International Muscle Strength and Nighttime Recovery Dietary Supplements

    AdvoCare International has commenced a voluntary recall of two lots of Muscle Strength and four lots of Nighttime Recovery dietary supplements because they may contain undeclared milk that can elicit an allergic reaction in individuals who are sensitive to milk and milk products. Learn more about the AdvoCare International dietary supplements recall

    AMA Wholesale Inc. Rhino 69 Extreme 50000

    AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. AMA Wholesale Inc. has not received any reports of adverse events related to this recall. Rhino 69 Extreme 50000 is packaged in single capsule, blister packs with an expiration date of 12/2022 and UPC Code: 718122071128. The product was distributed nationwide via internet sales to the customers. AMA Wholesale Inc. is notifying its customers by email and is arranging for return of the recalled product. Learn more about the AMA Wholesale Inc. Rhino 69 Extreme 50000 recall

    Club 13 Kratom Maeng Da Red Powder and Capsules

    Club 13 is recalling 15g, 30g, 90g, 150g, and 454g pouches and all bulk orders of "Maeng Da Red" kratom powder; 5-count, 25-count, 50-count, 100-count, and 120-count capsules and all bulk capsule orders of “Maeng Da Red” kratom bottles; and 5-count, 20-count, 25-count, 40-count, and 50-count capsules “Maeng Da Red XS” kratom bottles because they have the potential to be contaminated with Salmonella. Learn more about the Club 13 kratom Maeng Da Red recall

    Coastal Meds Sterile Products

    The FDA is alerting healthcare professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds LLC, due to visible particles in some of the drug vials for injection. During the FDA’s recent inspection of Coastal Meds, investigators observed visible particulates and poor sterile production practices, which further raised concerns about particulates in the drug products intended for injection. The FDA is not aware of any reports of adverse events associated with these drugs. Learn more about the Coastal Meds Sterile Products recall

    Epic Products Euphoric Capsules

    Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1-count blister cards (UPC 6-9685928646-9), 3-count bottles (UPC 6-9685928646-6), and 12-count bottles (UPC 6-9685928648-3) to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil. All lots of Euphoric are included in this recall. Euphoric was sold to consumers nationwide in the US via retail stores. Epic Products, LLC has discontinued sales of these products, is notifying its distributors and customers by email and phone calls, and is arranging for return of all recalled products. Consumers/distributors/retailers that have Euphoric which is being recalled should stop use/distribution and return to place of purchase. Learn more about the Epic Products Euphoric capsules recall

    MarcasUSA, LLC Pasta de Lassar Andrómaco Skin Protectant

    MarcasUSA, LLC and Industria Farmacéutica Andrómaco, S.A. de C.V. voluntarily recalled four lots of Pasta de Lassar Andrómaco skin protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta de Lassar Andrómaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US. However, due to the amount and type of contamination, the remaining four lots in the US market are being recalled out of an abundance of caution. Learn more about the MarcasUSA, LLC Pasta de Lassar Andrómaco skin protectant recall

    NutriZone Dietary Supplements

    NutriZone, LLC is recalling multiple dietary supplements due to the potential for contamination with Salmonella. Products include Pain Out Maeng Da, Pain Out Thai, Pain Out Malay, Nirvanio Green Malay, and Nirvanio Special Reserve Kratom Blend. They are also updating an incorrectly reported lot number provided in an earlier press release. Previously, NutriZone indicated the Pain Out Maeng Da lot number was 10957. The correct lot number is 10959. Consumers who have purchased the products should verify the lot number. Learn more about the NutriZone dietary supplements recall

    PDX Aromatics Kratom Powder

    PDX Aromatics, DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, has initiated a recall of certain kratom-containing powder products because it has the potential to be contaminated with Salmonella. The affected powder products are packaged in plastic heat sealed pouches and sold in 28g, 56g, and 112g. The products were sold directly to consumers via company websites between January 18, 2018 and February 18, 2018. The expanded recall also includes white vein and red vein powder and capsule products shipped between January 18, 2018 and March 8, 2018. Learn more about the PDX Aromatics kratom powder recall

    Premier Pharmacy Labs Sterile Injectable Products

    Premier Pharmacy Labs Issued a voluntary nationwide recall of specific sterile injectable products lots due to a potential lack of sterility assurance. Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. Products recalled include morphine sulfate 2mg/mL preservative-free (PF) injection, morphine sulfate 4mg/mL PF injection, hydromorphone hydrochloride 1mg/mL PF injection, and neostigmine methylsulfate 1mg/mL injection. Learn more about the Premier Pharmacy Labs sterile injectable products recall

    Tamarack Eclipse Kratom Powder

    Tamarack is voluntarily recalling Eclipse Kratom-containing powder products because it has the potential to be contaminated with Salmonella. The affected powder products are packaged in plastic heat sealed pouches or plastic sealed bottles sold in 1g capsules and powder. An estimated 120 units were sold directly to five retailers in Utah. Learn more about the Tamarack Eclipse kratom powder recall

    Triangle Pharmanaturals Kratom-containing Products

    The FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals after several were found to contain Salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. Learn more about the Triangle Pharmanaturals kratom-containing products recall

    FDA Alerts

    Analysis of United Pharmacy’s Compounded Glutamine, Arginine, and Carnitine Injectable

    FDA laboratory analysis found the glutamine in United Pharmacy’s compounded glutamine, arginine, and carnitine (GAC) 10/100/200mg/mL product for injection is degrading before the beyond-use date of 6 months specified on the product label. Previously, the FDA reported the product was labeled as including 10mg/mL of glutamine, but no glutamine was found in samples from lots GAC-12 or GAC-13 tested within expiry. Since that time, the FDA tested two available samples of the glutamine active pharmaceutical ingredient (API) collected from the API supplier used by United Pharmacy and determined the average purity of the samples to be within the acceptable range at 98.1% and 98.6% of its labeled claim. The FDA also further tested the United Pharmacy GAC-12 and GAC-13 samples to determine whether the glutamine degraded. United Pharmacy recalled all of its GAC 10/100/200mg/mL for injection products and ceased production of this formulation. Learn more about the analysis of United Pharmacy’s compounded glutamine, arginine, and carnitine injectable

    Highly Concentrated Caffeine in Dietary Supplements

    To better protect consumers from the dangers of highly concentrated and pure caffeine products, the FDA issued a new guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated caffeine and pure caffeine have been linked to at least two deaths in otherwise healthy individuals. Learn more about highly concentrated caffeine in dietary supplements