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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Comirnaty (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals aged 16 years and older. Comirnaty is the first COVID-19 vaccine to be granted approval by the FDA. Learn more about Comirnaty


    The FDA has approved Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Learn more about Exkivity

    Invega Hafyera

    The FDA has approved long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate), 6-month, the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Learn more about Invega Hafyera


    The FDA has approved Korsuva (difelikefalin) injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Korsuva injection is a first-in-class kappa opioid receptor agonist that targets the body’s peripheral nervous system. Learn more about Korsuva


    The FDA has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients aged one year and older with late-onset Pompe disease. Nexviazyme is an enzyme replacement therapy designed specifically to target the mannose-6-phosphate receptor. Learn more about Nexviazyme


    The FDA has approved Skytrofa (lonapegsomatropin-tcgd) for the treatment of pediatric patients aged one year and older who weigh at least 11.5kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone. Learn more about Skytrofa


    The FDA has approved Ticovac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals aged 1 year and older. Learn more about Ticovac


    The FDA has approved Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha inhibitor, for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery. Learn more about Welireg

    FDA First-Time Generic Approvals


    The FDA has approved the first generic version of Chantix (varenicline). The generic varenicline tablet will come in doses of 0.5mg and 1mg. Learn more about varenicline

    FDA Labeling Changes


    The FDA has approved a label update for Keytruda (pembrolizumab) for its indication in first-line advanced urothelial carcinoma. The FDA has converted this indication from an accelerated to a full (regular) approval. In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. Learn more about Keytruda

    FDA New Indications


    The FDA has approved Jardiance (empagliflozin) 10mg to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction. Learn more about Jardiance


    The FDA has approved a new indication for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. Learn more about Jemperli

    Keytruda Plus Lenvima

    The FDA has approved the combination of the anti-PD-1 therapy Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the first-line treatment of adult patients with advanced renal cell carcinoma. Learn more about Keytruda plus Lenvima


    The FDA has approved Opdivo (nivolumab) 240mg every two weeks or 480mg every four weeks (injection for intravenous use) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status. Learn more about Opdivo


    The FDA has approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test. Learn more about Tibsovo

    Xarelto Plus Aspirin

    The FDA has approved an expanded peripheral artery disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) to include patients following recent lower-extremity revascularization due to symptomatic PAD. Learn more about Xarelto plus aspirin


    The FDA has approved Xywav (calcium/magnesium/potassium/sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults. Learn more about Xywav

    FDA Recalls

    Azurity Firvanq

    Azurity is voluntarily recalling one lot of Firvanq (vancomycin hydrochloride) for oral solution, 50mg/mL kit to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle. Learn more about the Firvanq recall

    ICU Medical Aminosyn II

    ICU Medical, Inc. is voluntarily recalling one lot (2112 units) of Aminosyn II, 15%, an amino acid injection, sulfite-free, intravenous solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material, along with other particles. Learn more about the Aminosyn II recall

    Jacobus Pharmaceutical Company Ruzurgi

    Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi (amifampridine) 10mg tablets, to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria, based on laboratory test results. Learn more about the Ruzurgi recall

    Je Dois L’avoir Boutique 365 Skinny

    Je Dois L’avoir Boutique is voluntarily recalling all of the 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique, 30-day capsules supply to the retail/consumer level. The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique have been found to contain sibutramine. Learn more about the 365 Skinny recall

    Jongu 4308 Hydro Pineapple Burn

    eBay seller jongu 4308 is voluntarily recalling all lots of Hydro Pineapple Burn to the consumer level. FDA analysis has found the product to contain undeclared sibutramine. Learn more about the Hydro Pineapple Burn recall

    KVK Tech Atovaquone

    KVK Tech, Inc. is voluntarily recalling two lots of atovaquone oral suspension, USP 750mg/5mL, to the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment. Learn more about the atovaquone recall

    Pfizer Chantix

    Pfizer is voluntarily recalling all lots of Chantix 0.5mg and 1mg tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. Learn more about the Chantix recall

    SterRx Sodium Bicarbonate

    SterRx announced the voluntary nationwide recall of three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1000 mL due to waterborne microbial contamination. SterRx has initiated this voluntary recall of sodium bicarbonate injection, to the hospital pharmacy level. Learn more about the Sodium Bicarbonate recall

    Teligent Pharma Lidocaine HCl

    Teligent Pharma is voluntarily recalling one lot of lidocaine HCl topical solution 4%, 50mL in a screw cap glass bottle, to the user level. The product is being recalled because testing has found it to be super-potent based on an out-of-specification result obtained at the 18-month stability time point. Learn more about the Lidocaine HCl recall

    FDA Alerts

    JAK Inhibitors Drug Safety Communication

    The FDA has provided an update to the Drug Safety Communication issued on February 4, 2021. It has completed its review of a large, randomized safety trial and concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). The FDA is requiring new and updated warnings for the JAK inhibitors Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib). Learn more about the JAK Inhibitors Drug Safety Communication