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  • FDA Drug Updates

    FDA New Approvals

    Admelog

    The FDA approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway). Learn more about Admelog

    Auvi-Q

    The FDA has approved the first and only epinephrine autoinjector specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and children weighing 16.5 to 33 pounds (7.5 to 15kg). Auvi-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. The new 0.1mg-dose epinephrine auto-injector has a shorter needle length and a lower dose of epinephrine than current FDA-approved 0.15mg and 0.3mg epinephrine auto-injectors. Learn more about Auvi-Q

    Avastin

    The FDA has granted full approval for Avastin (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA's accelerated approval program. Avastin is now approved in the US for nine distinct uses across six different types of cancer. Learn more about Avastin

    Clenpiq

    FDA approval to market has been granted for Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a colonoscopy. With availability planned in Q1 2018, Clenpiq will be the only FDA-approved prescription colonoscopy prep that comes “ready-to-drink.” Learn more about Clenpiq

    Impoyz

    Dr. Reddy's Laboratories Ltd, through its wholly owned subsidiary Promius Pharma, LLC announced approval of Impoyz (clobetasol propionate) cream, 0.025%. Impoyz is a high potency topical steroid approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older. Learn more about Impoyz

    Juluca

    The FDA approved Juluca (dolutegravir and rilpivirine), the first complete treatment regimen containing only two drugs to treat certain adults with HIV-1 instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca. Learn more about Juluca

    Lonhala Magnair

    The FDA has approved Lonhala Magnair (glycopyrrolate inhalation solution) 25mcg twice daily for maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Lonhala Magnair is the first nebulized long-acting muscarinic antagonist approved by the FDA for the treatment of COPD. It is the first time the Magnair eFlow technology system, developed by PARI Pharma GmbH, has been used. Learn more about Lonhala Magnair

    Ogivri

    The FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the US for the treatment of cancer. Learn more about Ogivri

    Ozempic

    The FDA has approved Ozempic (semaglutide) as an adjunct to diet and exercise for the treatment of type 2 diabetes in adults. The long-acting glucagon-like peptide-1 (GLP-1) receptor agonist was approved in 0.5mg and 1.0mg doses, to be administered once weekly via a dedicated prefilled pen device. Ozempic is the seventh GLP-1 receptor agonist on the US market and the third dosed once weekly. Learn more about Ozempic

    Sublocade

    The FDA approved Sublocade (buprenorphine), the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days. Learn more about Sublocade

    FDA First-Time Generic Approvals

    Darunavir Ethanolate 600mg Tablets

    This new generic for Prezista is indicated or the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. Learn more about darunavir ethanolate

    Triamcinolone Acetonide Injectable Suspension

    Amneal received approval for its triamcinolone acetonide injectable suspension, USP in 40mg/mL dosage strength, making it the only available AP-rated generic equivalent to Kenalog-40 Injection. The product will be sold in 1mL single-dose vials as well as in 5mL and 10mL multiple dose vials. Learn more about triamcinolone acetonide

    FDA New Indications

    Isentress

    The FDA has approved Isentress (raltegravir), an integrase inhibitor, for use in combination with other antiretroviral agents, for the treatment of HIV-1 in neonates weighing at least 2kg. Learn more about Isentress

    Nucala

    The FDA expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA. Learn more about Nucala

    Repatha

    The FDA approved a supplemental application for Repatha (evolocumab), making it the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor indicated to prevent MI, stroke, and coronary revascularization in adults with established cardiovascular disease. The FDA also approved Repatha as an adjunct to diet, alone or in combination with other lipid-lowering therapies such as statins, for the treatment of adults with primary hyperlipidemia to reduce LDL cholesterol. Learn more about Repatha

    Taltz

    The FDA has approved Taltz (ixekizumab) injection 80mg/mL for the treatment of adults with active psoriatic arthritis. Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Learn more about Taltz

    FDA Recalls

    Nutra Labs. Inc Bull Capsules, Chao Jimengnan Tablets

    Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800mg capsules with the production date of 05/08/2016, and Chao Jimengnan 150mg tablets with Lot # 20151018, to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan, respectively. Sildenafil is the active pharmaceutical ingredient in an FDA-approved product used for erectile dysfunction, making Bull capsules and Chao Jimengnan tablets unapproved new drugs. Learn more about the Nutra Labs Inc. recall

    Sun Pharmaceutical Industries Riomet Oral Solution

    Sun Pharmaceutical Industries is recalling two lots of Riomet (metformin hydrochloride) oral solution, which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of entry of S. brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections. The affected Riomet includes product with NDC Code 10631-206-01 Lot A160031A, Exp.: 01/2018, and NDC 10631-206-02 Lot: A160031B, Exp.: 01/2018. Learn more about the Sun Pharmaceutical Industries recall

    FDA Alerts

    AlbuRx 25% 50mL and 100mL Vials

    During routine inspection of retained AlbuRx 25% (albumin human 25% injectable solution) samples, CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear-off portion of the vial label. This is limited to 50 and 100mL vial sizes. CSL Behring is taking no action with products on the market but is addressing the print settings to ensure readability throughout the shelf life of the product. If the lot number and expiration dating is not able to be verified, customers are asked to contact CSL Customer Support. CSL Behring recommends inspecting vial labels for readability and fading. If fading is evident, refer to the immediate carton for lot number and expiration dating. Additionally, the lot number is imprinted on the vial aluminum seal. Learn more about AlbuRx 25%

    Primus Pharmaceuticals Limbrel

    The FDA has recommended that Primus Pharmaceuticals voluntarily recall Limbrel (flavocoxid and citrated zinc bisglycinate), a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products. The FDA reminds consumers not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking this product should stop immediately and contact their healthcare provider. Healthcare providers who are aware that their patients are taking Limbrel should advise them to stop using it. Learn more about Limbrel

    Uloric

    The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with Uloric (febuxostat) compared the gout medicine called allopurinol. The FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009. Once the final results from the manufacturer are received, FDA will conduct a comprehensive review and will update the public with any new information. Learn more about Uloric