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  • FDA Drug Updates

    FDA New Approvals

    ALA HCl as Optical Imaging Agent for Gliomas

    The FDA approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan, NX Development Corp.) as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. Learn more about ALA HCl as an optical imaging agent for gliomas


    The FDA approved the fluoroquinolone Baxdela (delafloxacin), a new antibacterial drug to treat acute bacterial skin and skin structure infections. Baxdela is available for intravenous and oral use. Like all fluoroquinolones, it has a Boxed Warning to alert healthcare professionals and patients of increased risk of disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Baxdela is contraindicated for patients with known hypersensitivity to fluoroquinolones. Learn more about Baxdela


    The FDA approved Bevyxxa (betrixaban) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. The recommended dose of Bevyxxa is an initial single dose of 160mg starting on day 1, followed by 80mg once daily taken for 35 to 42 days at the same time each day with food. Learn more about Bevyxxa

    Cotempla XR-ODT

    The FDA granted approval to Cotempla XR-ODT (methylphenidate) for pediatric patients aged 6 to 17 years with ADHD. The recommended starting dose is 17.3mg given orally once daily in the morning. The dose could be titrated on a weekly basis from 17.3mg, to 25.9mg, to 34.6mg, and up to 51.8mg until an optimal dose or the maximum dose of 51.8mg/day is reached. Learn more about Cotempla XR-ODT


    The FDA granted approval to Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. Endari is the first treatment approved for patients with sickle cell disease in almost 20 years. Endari received Orphan Drug designation for this use, which provides incentives to assist and encourage the development of drugs for rare diseases. Learn more about Endari


    The FDA has approved Haegarda, the first C1 Esterase Inhibitor (human) for subcutaneous administration to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. Haegarda is a human plasma-derived, purified, pasteurized, lyophilized (freeze-dried) concentrate prepared from large pools of human plasma from U.S. donors. Haegarda is indicated for routine prophylaxis to prevent HAE attacks, but is not indicated for treatment of acute HAE attacks. Learn more about Haegarda


    The FDA has approved Mydayis (mixed salts of a single-entity amphetamine product) for ADHD. The once-daily treatment comprises three different types of drug-releasing beads and is formulated to last up to 16 hours. It is approved for adults and children aged 13 years and older with ADHD. Learn more about Mydayis


    The FDA has approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab. Nerlynx is a kinase inhibitor that works by blocking several enzymes that promote cell growth. Learn more about Nerlynx


    The FDA granted approval to Symjepi (epinephrine) for the emergency treatment of allergic reactions (type I), including anaphylaxis. Symjepi is a single dose injection of epinephrine intended for immediate administration as emergency supportive therapy for emergency treatment of allergic reactions in patients who weigh 66 pounds or more and is not intended as a substitute for immediate medical care. Learn more about Symjepi


    Janssen Biotech, Inc. announced that the FDA approved Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Approval comes after an expedited regulatory review following application of an FDA Priority Review Voucher. Tremfya is administered as a 100mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. Learn more about Tremfya


    The FDA granted approval to Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs, sofosbuvir and velpatasvir, and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A. Learn more about Vosevi

    FDA First-Time Generic Approvals

    Atomoxetine Capsules USP, 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg

    This new generic for Strattera is indicated for the treatment of ADHD. Learn more about atomoxetine capsules

    Doxycycline Hyclate Tablets USP, 75mg, 150mg

    This new generic for Acticlate is indicated for treatment of rickettsial, sexually transmitted, respiratory tract, ophthalmic, and specific bacterial infections; anthrax, including inhalational anthrax (post-exposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy for acute intestinal amebiasis and severe acne; and prophylaxis of malaria. Learn more about doxycycline hyclate tablets

    Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200mg/300mg

    The FDA approved the first generic version of Truvada. It is indicated for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. It is indicated for treatment in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17kg. Learn more about emtricitabine and tenofovir disoproxil fumarate tablets

    Mesalamine Delayed-Release Tablets USP, 1.2g

    This new generic for Lialda is indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. Learn more about mesalamine delayed-release tablets

    Paroxetine Capsules, 7.5mg

    This new generic for Brisdelle is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. Learn more about paroxetine capsules

    Phentermine Hydrochloride Orally Disintegrating Tablets, 15mg, 30mg, 37.5mg

    This new generic for Suprenza is indicated for use as a short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity for certain patients. Learn more about phentermine hydrochloride orally disintegrating tablets

    Prasugrel Tablets, 5mg, 10mg

    This new generic for Effient is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in certain patients with acute coronary syndrome who are to be managed with PCI. Learn more about prasugrel tablets

    Sevelamer Carbonate Powder for Oral Suspension, 0.8g, 2.4g

    This new generic for Renvela is indicated for the control of serum phosphorus in adults with chronic kidney disease on dialysis. Learn more about sevelamer carbonate powder for oral suspension

    FDA Labeling Updates


    The FDA approved a safety labeling change for Advil (ibuprofen) that includes updated warnings and precautions explaining the risk of heart attack and stroke, advisement for patients to contact their healthcare provider before using if the patient has a history of stroke, and instruction to stop use and talk with their healthcare provider if any symptoms of heart problem or stroke arise. Learn more about Advil

    Biaxin, Biaxin XL

    The FDA approved safety labeling changes for Biaxin and Biaxin XL (clarithromycin) regarding all-cause mortality in patients with coronary artery disease 1 to 10 years following Biaxin exposure. In one clinical trial evaluating treatment with clarithromycin on outcomes in patients with coronary artery disease, an increase in risk of all-cause mortality one year or more after the end of treatment was observed in patients randomized to receive clarithromycin. Clarithromycin for treatment of coronary artery disease is not an approved indication. The cause of the increased risk has not been established. Other epidemiologic studies evaluating this risk have shown variable results. Learn more about Biaxin

    FDA New Indications

    DigniCap Cooling System

    The FDA cleared the expanded use of a cooling cap, the DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. Learn more about the DigniCap


    The FDA expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations to 33. Kalydeco is indicated for patients aged 2 and older who have one mutation in the CFTR gene that is responsive to drug treatment based on clinical and/or in vitro (laboratory) data. Learn more about Kalydeco

    Sapien 3 Transcatheter Heart Valve (THV)

    The FDA has approved an expanded indication for the Sapien 3 THV for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater. Learn more about the Sapien 3 THV

    FDA Recalls

    Advanced Pharma, Inc. Injectable Solutions

    Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is conducting a limited, voluntary recall due to Hospira’s June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process, and therefore there was a lack of sterility assurance. The products being recalled by Advanced Pharma were repackaged and/or compounded at its Houston, Texas facility using certain Hospira products. The recalled products are specific lots of potassium phosphate and succinylcholine chloride. This is a secondary recall based on Hospira's recent recall. Learn more about Advanced Pharma’s injectable solutions recall

    Advanced Pharma, Inc. Nitroglycerin Injection in 5% Dextrose

    Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of compounded nitroglycerin injection which would lead to a lower dose being administered. While the lower than expected potency results affected only certain lots of nitroglycerin, Advanced Pharma is recalling all unexpired lots of nitroglycerin. The recalled nitroglycerin products include the 100mcg per mL and 200mcg per mL strengths available in 5mL, 10mL, and 20mL sterile single dose syringes and are packaged in various sizes per carton. These products were distributed nationwide in the U.S. between March 9, 2017 and June 1, 2017 and have expiration dates ranging from June 9, 2017 to August 15, 2017. The issue is segregated to the Houston Avella location. Learn more about the Advanced Pharma nitroglycerin in 5% dextrose recall

    Alvogen Clindamycin Injection ADD-Vantage Vials

    Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira. In the event that impacted product is administered, there is a reasonable probability that the patient may experience adverse events, ranging from fever, chills, and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Learn more about the Alvogen Clindamycin Injection ADD-Vantage Vials recall

    Andropharm Sten Z and M1 Alpha Capsules

    Andropharm is voluntarily recalling all lots of Sten Z and M1 Alpha capsules to the consumer level because these products contain derivatives of anabolic steroids, rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall. Consumption of these products may cause elevated blood pressure, aggressive behavior, male infertility, or enlarged breasts and shrinkage of the testes in men. Patients with underlying cardiac, hepatic, or prostate conditions may be at higher risk for adverse reactions than otherwise healthy users. To date, Andropharm has not received any reports of these or any illnesses or injuries related to Sten Z or M1 Alpha. Learn more about the Andropharm Sten Z and M1 Alpha capsules recall

    Eliquis 5mg Tablets

    One lot of Eliquis (apixaban) 5mg tablets is being voluntarily recalled after a consumer complained that a bottle labeled as Eliquis 5mg actually contained 2.5mg tablets. Patients who are prescribed Eliquis 5mg for atrial fibrillation and take a 2.5mg tablet instead, particularly for a prolonged period, could have an increased probability of stroke, a moving blood clot, or death. For patients with deep vein thrombosis and pulmonary embolism, underdosing of the drug could lead to an increased risk of a growing or moving blood clot. The company notes the two tablets differ in strength but also in color, size, and markings, which should decrease the likelihood of an incorrect dose. The 2.5mg tablet is round and yellow with "893" printed on one side and "2½" on the other side, whereas the 5mg tablet is pink and oval with "894" printed on one side and "5" on the flip side. The recalled lot is HN0063, Exp 09/2019, NDC 0003-0894-2 and was distributed in February 2017. Learn more about the Eliquis 5mg tablets recall

    Fagron Injectable Solutions

    Fagron Sterile Services is voluntarily recalling three lots of succinylcholine chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira and repacked by Fagron Sterile Services is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which represents the potential introduction of microorganisms into the product. Learn more about the Fagron injectable solutions recall

    Hardcore Formulations Ultra-Sten and D-Zine Capsules

    Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level. These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids in Ultra-Sten and D-Zine render them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall. To date, Hardcore Formulations has not received any reports of these or any other illnesses or injuries related to Ultra-Sten or D-Zine. Ultra-Sten and D-Zine capsules are marketed as dietary supplements for bodybuilding and are packaged in 90-count bottles, with the barcode 7-48252-68763-0 (Ultra-Sten); 7-48252-86193-1 (D-Zine). This recall applies to all lot numbers and expiration dates of these products. Ultra-Sten and D-Zine capsules were distributed nationwide in the U.S. to retailers from August 2014 to May 2017. Learn more about the Hardcore Formulations Ultra-Sten and D-Zine Capsules recall

    Hospira Injectable Solutions

    Hospira has voluntarily recalled a large quantity of injectable solutions due to doubts regarding product sterility. The recall was ordered due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. So far, Hospira has not identified any cases of microorganisms contaminating the solutions under recall, nor has it received any reports of adverse events linked to their usage. The injectables involved are the following: 42 lots of 8.4% sodium bicarbonate injection 50mL vials, five lots of sodium bicarbonate 4% additive solution (Neut) 5mL vials, five lots of succinylcholine chloride injection (Quelicin) 200mg/10mL vials, and seven lots of potassium phosphates injection 45mM vials. Learn more about the Hospira injectable solutions recall

    Novo Nordisk NovoPen Echo Insulin Cartridge Holders

    Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar. The affected batches were distributed between 8/1/2016 and 6/22/2017 to distributors, sales representatives, and replacement programs for further distribution to pharmacies, healthcare providers, and patients nationwide. Novo Nordisk is notifying distributors, pharmacies, healthcare professionals, and patients by mail and is arranging for product replacement. Learn more about the Novo Nordisk NovoPen Echo insulin cartridge holders recall

    Oscor ATAR Extension Cables

    The ATAR cable is an extension cable with connector(s) on both sides, designed to connect with various receptacles or cables/leads, depending on the instrument being used. During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use. This event resulted in cable malfunction, causing interruption of the pacing system. Oscor received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries. No deaths were reported. Learn more about the Oscor ATAR Extension Cables recall

    PharMEDium Services Injectable Solutions

    PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira products. The recalled products are specific lots of potassium phosphate and succinylcholine chloride. This is a secondary recall based on Hospira's recent recall. Learn more about the PharMEDium Services injectable solutions recall

    Phillips Company Topical Products

    Phillips Company is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain, and LidoMed. The products are being recalled after an FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality, and purity of unexpired drug products made at the firm during the past three years. Learn more about the Phillips Company topical products recall

    Teva Paliperidone Extended-Release Tablets

    Teva has initiated a voluntary recall of a single lot of paliperidone extended-release tablets because it failed test results for dissolution, which could reduce its efficacy. The drug is used to treat schizophrenia and schizoaffective disorders. The recall includes paliperidone extended-release tablets 3mg, 90-count bottles, lot 1160682A, expiration 6/2018, NDC 0591-3693-19, distributed under the Actavis Pharma, Inc, label. Taking a product for the treatment of schizophrenia and schizoaffective disorders that has failed dissolution could result in less drug being absorbed. If two or more consecutive dosing regimens exist with an affected product, failure to maintain therapeutic levels could occur, which could reduce effectiveness in treating a patient's mental and/or mood symptoms including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, and aggressive behavior, as well as vocal and motor tics. Learn more about the Teva paliperidone extended-release tablets recall

    Vascular Solutions Inc. Venture Catheters

    Vascular Solutions Inc. is recalling the Venture catheter because there is a risk of the catheter tip splitting or separating during use. Excess material at the tip of the catheter may separate and could enter the patient's bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death. All unexpired lots of the Rapid Exchange (RX), Over-the-Wire (OTW), and Coronary Sinus (CS) versions of the product have been recalled. This includes Venture RX Catheter (Model 5820), Venture OTW (Model 5821), and Venture CS Catheter (Model 5822). Learn more about the Vascular Solutions Inc. Venture catheters recall

    FDA Alerts

    Datascope Corp. Intra-Aortic Balloon Pumps

    Datascope Corp. is voluntarily performing a worldwide field correction of certain intra-aortic balloon pumps (IABPs) for a potential electrical test failure code. This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP. Datascope received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. Patients receiving IABP therapy are in critical condition, and sudden interruption of therapy could result in unsafe, hemodynamic instability. The affected IABP units were distributed in the U.S. and worldwide. Affected units were distributed between March 23, 2003 and December 11, 2013. Learn more about Datascope Corp. IABPs

    Frameless Stereotaxic Navigation Systems

    Stereotaxic navigation systems include a computer system that utilizes patient imaging (e.g., CT, MRI) to guide surgeons with the placement of specialized surgical instruments and implants before and during the procedure. Stereotaxic systems are generally considered framed or frameless. The FDA is aware that some healthcare providers have experienced navigational accuracy errors during surgical procedures when using frameless stereotaxic navigation systems. Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures. The FDA believes that there are many factors that contribute to these errors, and no particular system carries greater risk than others. The FDA is working with device manufacturers to ensure accurate labeling that includes clear user instructions on how to minimize the occurrence of these issues. The FDA will keep the public informed as significant new information becomes available. Learn more about frameless stereotaxic navigation systems

    Opana ER Tablets

    The FDA has requested that Endo, the manufacturer of Opana ER, initiate a voluntary recall of the drug, stating that the medication, which was supposed to be “abuse deterrent,” has been linked to widespread problems and has contributed to outbreaks of HIV and hepatitis C. The FDA determined that Opana ER needs to be recalled from the market based on a study of postmarketing data and recommendations by an independent advisory committee in March, which voted that the Opana ER risks outweigh its benefits. If Endo does not remove Opana ER from the market, the FDA will take action to have the drug forcibly recalled. Learn more about Opana ER tablets

    Sonar Products and Stratus Pharmaceuticals Unapproved Drugs

    Sonar Products and Stratus Pharmaceuticals have been ordered to cease manufacturing and distributing unapproved drugs. According to the complaint filed, Stratus and Sonar routinely shipped unapproved, improperly labeled (misbranded), and substandard or contaminated (adulterated) drugs in interstate commerce. Specifically, Sonar manufactured and Stratus distributed a number of dermatological products, including various washes, creams, and ointments that were not approved by the FDA. Learn more about Sonar Products and Stratus Pharmaceuticals unapproved drugs