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  • FDA Drug Updates

    FDA New Approvals

    Adhansia XR

    The FDA has approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, a central nervous system stimulant, for the treatment of attention-deficit/hyperactivity disorder in patients aged six years and older. Learn more about Adhansia XR

    Esperoct

    The biologics license application for Esperoct (antihemophilic factor (recombinant), glycopegylated-exei) for the treatment of adults and children with hemophilia A has been approved by the FDA. Esperoct is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment, and control of bleeding episodes and perioperative management of bleeding. Learn more about Esperoct

    Gloperba

    The FDA has approved Gloperba (colchicine) oral solution 0.6mg/5mL for prophylaxis of gout flares in adults. Gloperba is the first liquid formulation of colchicine approved by the FDA for the prophylaxis of gout flares. It will be available across the US in summer 2019. Learn more about Gloperba

    Herceptin Hylecta

    The FDA has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease. Learn more about Herceptin Hylecta

    Lotemax SM

    The FDA has approved Lotemax SM (loteprednol etabonate) ophthalmic gel 0.38% for postoperative inflammation and pain associated with ocular surgery. Lotemax SM uses submicron particles to facilitate adherence to the ocular surface and penetration of the aqueous humor and important ocular tissues. Learn more about Lotemax SM

    Spravato

    The FDA has approved Spravato (esketamine) CIII nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have treatment-resistant depression. Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a REMS. Learn more about Spravato

    Trazimera

    The FDA has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Learn more about Trazimera

    FDA New Indications

    Keytruda

    The FDA approved Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. The recommended dose of Keytruda for the adjuvant treatment of adult patients with melanoma is 200mg administered as an intravenous infusion over 30 minutes every three weeks until disease recurrence, unacceptable toxicity, or for up to 12 months in patients without disease recurrence. Learn more about Keytruda

    Lonsurf

    The FDA has approved Lonsurf as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. This approval expands the current indication for Lonsurf in the US, where it is currently approved for the treatment of patients with metastatic colorectal cancer who have been previously treated with standard chemotherapy. Learn more about Lonsurf

    Tecentriq with Abraxane

    The FDA has granted accelerated approval to Tecentriq (atezolizumab) plus chemotherapy (Abraxane (paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel)) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumors express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Learn more about Tecentriq with Abraxane

    FDA Recalls

    American Health Packaging Valsartan Tablets

    American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging. Product was distributed nationwide to wholesalers for use in hospital settings. No reports of injury or adverse events to date. Learn more about the American Health Packaging recall

    Apotex Corp. Drospirenone and Ethinyl Estradiol Tablets

    Apotex Corp. is voluntarily recalling four lots of drospirenone and ethinyl estradiol tablets, USP to the patient/user level. The four recalled lots may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. Apotex Corp. has notified its affected wholesalers and distributors and is arranging for return of all recalled product. Learn more about the Apotex Corp. recall

    AurobindoPharma USA, Inc. Amlodipine Valsartan Tablets and Valsartan Tablets

    AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of valsartan and amlodipine and valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18. Learn more about the AurobindoPharma USA, Inc. recall

    Camber Pharmaceuticals Losartan Potassium Tablets

    Camber Pharmaceuticals, Inc. is recalling 87 lots of losartan tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to the detection of trace amounts of N-methylnitrosobutyric acid. Camber has not received any reports of adverse events related to this recall. Learn more about the Camber Pharmaceuticals recall

    Golean Detox USA Golean DETOX Capsule

    Golean Detox USA is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. This tainted product is marketed as a dietary supplement for weight loss and is packaged in 14 packets containing 2 capsules per packet, a total of 28 capsules per box, UPC 8 938510 909013. Learn more about the Golean Detox USA recall

    Macleods Pharmaceuticals Losartan Potassium/HCTZ Combination

    Macleods Pharmaceuticals Limited is voluntarily recalling one lot of losartan potassium/HCTZ combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (N-nitrosodiethylamine) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited. Learn more about the Macleods recall

    McDaniel Life-Line LLC Life-Line Water

    McDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa. Use of the contaminated product has a remote probability of necessitating medical or surgical intervention to preclude or reverse permanent damage to a body structure or function. Learn more about the McDaniel Life-Line LLC Life-Line water recall

    Sunstone Organics Kratom Products

    Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella. Learn more about the Sunstone Organics Kratom products recall

    Torrent Pharmaceuticals Losartan Products

    Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of losartan potassium tablets USP and 54 lots of losartan potassium/HCTZ tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Hetero Labs Limited. The impurity detected is N-methylnitrosobutyric acid. Learn more about the Torrent Pharmaceuticals losartan products recall

    FDA Alerts

    Chantix Not Recommended in Pediatric Patients

    The FDA approved changes to the prescribing information for Chantix (varenicline). These changes specify that the drug is not recommended for pediatric patients aged 16 years or younger because its efficacy in this population was not demonstrated. Learn more about Chantix

    Uloric

    The FDA has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric. Learn more about Uloric

    Xeljanz

    The FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). The FDA has not approved this 10mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis. In this ongoing safety trial required by FDA when it approved tofacitinib for RA, the drug manufacturer, Pfizer, is transitioning patients who were on the high 10mg twice daily dose to the lower, currently approved dose of 5mg twice daily. This trial will continue and is expected to be completed by the end of 2019. Learn more about Xeljanz