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  • FDA Drug Updates

    FDA New Approvals

    Humalog U-200 KwikPen

    Eli Lilly and Company announced that the FDA has approved Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes. Learn more about Humalog U-200 KwikPen

    Invega Trinza

    Janssen Pharmaceuticals, Inc. announced that the FDA approved under priority review the New Drug Application for the 3-month long-acting atypical antipsychotic Invega Trinza. Invega Trinza, a 3-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Learn more about Invega Trinza

    Meropenem in Duplex Containers

    B. Braun Medical Inc. announced that it received FDA approval for 500mg Meropenem for Injection USP and Sodium Chloride Injection USP and 1g Meropenem for Injection USP and Sodium Chloride Injection USP in B. Braun’s Duplex Container. The Duplex container speeds dispensing and saves time and labor because it can be stored in an automated dispensing cabinet in healthcare settings. A barcode that references the final admixture, lot number, and expiration date helps reduce medication errors, automate patient charting, track inventory, and facilitate reimbursement tracking. With the addition of Meropenem to its drug delivery portfolio, B. Braun has expanded its offering of intravenous antibiotic therapies via its Duplex container. Learn more about Meropenem in Duplex Containers

    Senza System

    The FDA approved the Senza spinal cord stimulation system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain, and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 kHz) and low stimulation amplitudes. Learn more about the Senza System

    Stiolto Respimat

    Boehringer Ingelheim announced that the FDA approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray. It has been approved as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. Learn more about Stiolto Respimat


    Actavis announced that Viberzi (eluxadoline) was approved by the FDA as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea. Viberzi has mixed opioid receptor activity; it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist. Pending final scheduling designation, product launch is anticipated in Q1 2016. Learn more about Viberzi

    FDA New Indications


    The FDA has approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox is also approved for prevention of plague in adult patients. Learn more about Avelox


    The antibiotic meropenem was approved by the FDA for treating abdominal infections in children less than 3 months of age. Meropenem is a broad spectrum antibiotic—effective against a wide variety of bacteria. The drug has been previously approved to treat complicated intra-abdominal infections and complicated skin infections in adults and older children, and for treating children 3 months of age and older with bacterial meningitis. Learn more about Meropenem

    Qudexy XR

    Upsher-Smith Laboratories, Inc. announced that it has received FDA approval of a supplemental New Drug Application for Qudexy XR (topiramate) extended-release capsules for use as initial monotherapy in patients 2 years of age and older who are experiencing partial-onset seizures or primary generalized tonic-clonic seizures. Qudexy XR was previously approved for use as initial monotherapy in patients 10 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures. Qudexy XR is also approved as an adjunctive therapy in patients 2 years of age or older with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Learn more about Qudexy XR


    The FDA has approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis, a rare, progressive lung disease that primarily affects women of childbearing age. Rapamune, which is available as both a tablet and an oral solution, was originally approved in 1999 as an immunosuppressive agent to help prevent organ rejection in patients 13 years and older receiving kidney transplants. Learn more about Rapamune


    Pernix Therapeutics Holdings, Inc. announced that the FDA has approved Treximet (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura. Learn more about Treximet


    Salix Pharmaceuticals, Inc. has received approval from the FDA for Xifaxan 550mg for the treatment of irritable bowel syndrome with diarrhea in adults. Xifaxan 550mg is also FDA-approved to manage hepatic encephalopathy. Learn more about Xifaxan

    FDA First-Time Generic Approvals

    Generic Mucinex D

    Actavis and its partner Perrigo Company announced that Actavis has received FDA approval for its Abbreviated New Drug Application for guaifenesin/pseudoephedrine tablets and that Perrigo will begin shipments in time for the cough/cold season to its retail and wholesale customers in the US. Learn more about Generic Mucinex D

    FDA Recalls

    Avea Ventilators

    The recall is in response to a potential malfunction of an Avea ventilator-specific 5 psi pressure transducer. The affected Avea ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve, and stops ventilating. If this occurs, alternate ventilation support will be required to reduce the potential of hypoxemia or hypercapnia. The global recall involves Avea ventilators manufactured, serviced, and distributed from July 1, 2011 to March 15, 2015. Learn more about Avea Ventilators

    Mylan Injectable Products

    Mylan has announced that its US-based Mylan Institutional business is expanding its voluntary nationwide recall to the hospital/user level of select lots of Gemcitabine for Injection and Methotrexate Injection due to the presence of visible foreign particulate matter observed during testing of retention samples. Learn more about Mylan Injectable Products

    Smart Lipo

    SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950mg) capsules, to the consumer level. The FDA received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. Learn more about Smart Lipo

    Tiger Paw System II

    The FDA announced a Class I Recall of all lots of the Tiger Paw System II by Maquet Medical Systems. Incomplete closure of the Tiger Paw System II may result in tissue tears and/or bleeding, including a possible tear on the left atrial wall (top left chamber) during use of the device. The Tiger Paw II is a surgical staple used to close tissue in the left atrial appendage of the heart. The affected devices were distributed from April 1, 2013 through March 23, 2015. Learn more about the Tiger Paw System II

    Vascu-Guard Peripheral Vascular Patch

    Baxter International Inc. announced it is voluntarily recalling four product codes of its Vascu-Guard Peripheral Vascular Patch. Baxter received customer complaints of difficulty in distinguishing the smooth from rough surface of the Vascu-Guard patch as described in the labeled instructions for use. This is due to a deviation in the surface texture of the vascular patch in a new packaging configuration. Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Learn more about the Vascu-Guard Peripheral Vascular Patch

    FDA Alerts

    LifeCare PCA3 and PCA5 Infusion Pump Systems

    The FDA and Hospira have become aware of security vulnerabilities in Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems. An independent researcher has released information about these vulnerabilities, including software codes, which, if exploited, could allow an unauthorized user to interfere with the pump’s functioning. An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies. Learn more about the LifeCare PCA3 and PCA5 Infusion Pump Systems

    SGLT2 Inhibitors

    The FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Learn more about SGLT2 Inhibitors

    Testosterone Products

    The FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. The FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. The FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. Learn more about Testosterone Products

    Unintentional Injection of Soft Tissue Filler

    The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke, and damage and/or death of the skin (necrosis) and underlying facial structures. Learn more about Unintentional Injection of Soft Tissue Filler


    The FDA is warning healthcare professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling. Learn more about Zerbaxa