FDA New Approvals
Neos Therapeutics, Inc. announced that the FDA approved Adzenys XR-ODT (Amphetamine\extended-release orally disintegrating tablets) for the treatment of ADHD in patients six years and older. Full field force launch and product shipments will begin in the second quarter of 2016.
Learn more about Adzenys XR-ODT
Impax Laboratories, Inc. announced that the
FDA has approved the supplemental new drug application for Emverm (mebendazole)
100mg chewable tablets. Emverm is indicated for the treatment of Enterobius vermicularis
trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale
(common hookworm), and Necator
americanus (American hookworm) in single or mixed infections. Impax
expects to initiate commercial distribution of Emverm early in the second
quarter of 2016.
Learn more about Emverm
Avanir Pharmaceuticals, Inc. announced that the FDA has approved Onzetra Xsail (sumatriptan nasal powder) for the acute treatment of migraine with or without aura in adults. Onzetra Xsail is an intranasal medication delivery system consisting of a low dose (22mg) of sumatriptan powder that is delivered utilizing the novel Xsail Breath Powered Delivery Device.
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Dr. Reddy’s announced that its US subsidiary, Promius Pharma, LLC, has received approval for Sernivo (betamethasone dipropionate) Spray, 0.05% from the FDA. Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter.
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Dr. Reddy's Laboratories announced that the FDA has approved ZembraceSymTouch (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. ZembraceSymTouch is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. The injection is intended to be given subcutaneously.
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Merck announced that the FDA has approved Zepatier (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus genotype (GT) 1 or GT4 infection, with or without ribavirin, following priority review by the FDA. Zepatier (pronounced ZEP-ah-teer) is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50mg) and the NS3/4A protease inhibitor grazoprevir (100mg).
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FDA First-Time Generic Approvals
Generic Version of Gleevec
Sun Pharma announced the launch of Imatinib Mesylate Tablets (therapeutic equivalent to Gleevec for indications approved by the FDA) in the US market.
Learn more about Generic Version of Gleevec
FDA New Dose Forms
NextSource Biotechnology, LLC announced that Gleostine (lomustine) 5mg capsules has been approved by the FDA and is now commercially available in the US. Gleostine is approved for use as a single agent treatment or in combination with other approved chemotherapeutic agents. Gleostine is indicated to treat brain tumors—both primary and metastatic, as well as Hodgkin's disease. This approval adds a fourth dosage strength to the Gleostine product lineup that now includes 5, 10, 40, and 100mg strengths.
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FDA New Formulations
Takeda Pharmaceuticals U.S.A., Inc. announced that the FDA approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient’s mouth. Dexilant SoluTab is a proton pump inhibitor indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease and the maintenance of healed erosive esophagitis and relief of heartburn in adults 18 years and older. In addition to Dexilant SoluTab, Dexilant is also available as a capsule.
Learn more about Dexilant SoluTab
Humulin R U-500 KwikPen
The FDA has approved Eli Lilly and Company's Humulin R U-500 KwikPen (insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day.
Learn more about Humulin R U-500 KwikPen
FDA New Indications
Animas Vibe System
Animas Corporation announced that the FDA has approved the use of the Animas Vibe Insulin Pump and Continuous Glucose Monitoring System for the management of diabetes in children and adolescents, ages two to 17. The Animas Vibe System allows patients and their caregivers to view glucose data and administer insulin right from the pump.
Learn more about the Animas Vibe System
The FDA has approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab.
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Allergan announced that the FDA has approved Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. Botox was first approved for the treatment of upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist, and fingers, in adults in March 2010. Additional FDA approval was received in April 2015 to expand the Botox label for the treatment of adults with ULS to include the addition of two thumb muscles.
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Bristol-Myers Squibb Company announced that Daklinza (daclatasvir, 60mg), an NS5A replication complex inhibitor, has been approved by the FDA in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic hepatitis C virus genotype 3.
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Merck announced that the FDA has approved a supplemental new drug application for single-dose Emend (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). With this approval, Emend for injection is approved in the US for both highly emetogenic chemotherapy as well as MEC.
Learn more about Emend
Eisai Co., Ltd. announced that its US subsidiary Eisai Inc. has received approval from the FDA for its in-house developed anticancer agent Halaven (eribulin mesylate) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. Following approval for use in the treatment of metastatic breast cancer in the US, this marks the second indication for which Halaven has been approved by the FDA.
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Integra Omnigraft Dermal Regeneration Matrix
Integra LifeSciences Holdings Corporation announced that the FDA has approved the PMA Supplement for Integra Dermal Regeneration Template (IDRT) for the treatment of diabetic foot ulcers (DFUs). IDRT, with its newly approved DFU indication, will be marketed under the name Integra Omnigraft Dermal Regeneration Matrix.
Learn more about Integra Omnigraft Dermal Regeneration Matrix
Amgen announced that the FDA has approved the supplemental New Drug Application of Kyprolis (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This new indication for Kyprolis is the second in six months.
Learn more about Kyprolis
Opdivo + Yervoy
Bristol-Myers Squibb Company announced that the FDA has approved Opdivo (nivolumab) in combination with
Yervoy (ipilimumab) for the
treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or
metastatic melanoma. This approval expands the original indication for the Opdivo + Yervoy Regimen for the
treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to
include patients regardless of BRAF mutational status.
Learn more about Opdivo + Yervoy
Abbott’s Compounding Pharmacy Sterile Compounded Products
Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California. All recalled products have a label that includes the Abbott's Compounding Pharmacy name and expiration date. If unsure, customers can call the pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.
Learn more about Abbott’s Compounding Pharmacy Sterile Compounded Products
Baxter IV Solutions
Baxter is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. Leaking containers could result in contamination of the solution. If not detected, this could lead to a bloodstream infection, worsened patient condition, or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack, damage to other organs such as the kidney or liver, or death.
Learn more about Baxter IV Solutions
Brainlab Cranial Image-Guided Surgery (IGS) System
Brainlab is recalling the Cranial IGS System due to potential inaccuracies in the display by the navigation system compared to the patient anatomy. This could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries, including death. This recall includes the Brainlab Cranial IGS System and Brainlab Cranial Navigation Systems (all existing versions before Cranial 3.0), distribution dates: May 1996 to May 2015.
Learn more about Brainlab Cranial Image-Guided Surgery (IGS) System
Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid
Perrigo Company announced that, following the recent recall of certain dosing cups by its supplier, it has initiated a voluntary product recall in the US to the retail level of 2 batches of its children's guaifenesin grape liquid (100mg/5mL) and 3 batches of its children's guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/5mL) sold in 4 oz. bottles with dosage cup in a box under multiple store brand product names. Some packages contain an oral dosing cup with incorrect dose markings.
Learn more about Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid
L.G Compounded Asafoetida Powder
Shakti Group USA LLC is recalling 50g and 100g sizes of L.G Compounded Asafoetida Powder, both coded with Lot Number: 2323 because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail, or elderly people, and others with weakened immune systems. The recall is a result of sampling conducted by the FDA that revealed that the finished products contained the bacteria.
Learn more about L.G Compounded Asafoetida Powder
Licorice Coughing Liquid
Master Herbs, Inc. is voluntarily recalling all lots of Licorice Coughing Liquid, cough syrup in 100mL bottles to the consumer level. This product has been found to contain morphine, which is an opioid, and it is not declared on the label. Consumers using this product may not be aware they are ingesting morphine. The unware ingestion of morphine can lead to life-threatening respiratory depression and death. Because the morphine contained in this product is not identified on the label, there is a risk that patients who are hypersensitive to morphine could suffer severe allergic reactions. In addition, young children with a respiratory illness are vulnerable to respiratory depression from opioids and should not be exposed to morphine in any event.
Learn more about Licorice Coughing Liquid
MOVES Ventilator System
Thornhill Research Inc. is recalling the MOVES ventilator system because excess glue on the battery connectors may prevent the battery from powering the device after the battery is stored. This issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death.
Learn more about MOVES Ventilator System
Optisure Dual Coil Defibrillation Leads
St. Jude is recalling the Optisure leads due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils. Depending on device programming and the depth of the cut, this could result in the inability of the defibrillator to deliver electrical therapy to the patient. The use of affected products may cause serious adverse health consequences, including patient injury or death.
Learn more about Optisure Dual Coil Defibrillation Leads
Pink Bikini and Shorts on the Beach Dietary Supplements
Lucy's Weight Loss System is voluntarily recalling all lots of Pink Bikini and Shorts on the Beach Capsules in all colors, 30 count (750mg per capsule) to the consumer level. Pink Bikini and Shorts on the Beach may contain an undeclared active pharmaceutical ingredient. FDA analysis of Pink Bikini (white capsules, blue capsules, and gold capsules) and Shorts on the Beach (blue capsules and gold capsules) found these products to be tainted with sibutramine, phenolphthalein, and/or diclofenac, and that these active ingredients are not declared on the label of the product. The affected Pink Bikini and Shorts on the Beach lots include the following expiration date: 7/30/2017. These products were distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store.
Learn more about Pink Bikini and Shorts on the Beach Dietary Supplements
Pleural and Pneumopericardial Drainage Sets
Stryker Sustainability Solutions received two reports that the catheter included in the Drainage Set broke off in the pleural cavity while inserting the device into the patient. Both cases resulted in the need for medical intervention. This issue could cause serious patient injury or death.
Learn more about Pleural and Pneumopericardial Drainage Sets
Products by R Thomas Marketing
R Thomas Marketing LLC is voluntarily recalling all lots of select products to the consumer level. These products were tested by the FDA and found to contain sildenafil, a PDE-5 inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction making this tainted dietary supplement and unapproved drug. This undeclared active ingredient poses a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Learn more about Products by R Thomas Marketing
Spotchem II Test Strips
Arkray is recalling the Spotchem II Basic Panel-1 Reagent Test Strip and Spotchem II Glucose Reagent Test Strip because they may report falsely low blood glucose levels. Because the test strips are reporting falsely low blood glucose when the true levels are above 265mg/dL, there is a risk that the healthcare provider would not diagnose hyperglycemia (high blood sugar) including diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in a timely manner and fail to treat elevated blood glucose levels.
Learn more about Spotchem II Test Strips
Bentonite Me Baby
The FDA is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk. The product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions. Consumers should not purchase or use “Bentonite Me Baby.” Anyone who has used this product or provided it to a child should consult a healthcare professional immediately. FDA laboratory analysis of the product found elevated lead levels. Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.
Learn more about Bentonite Me Baby
Crema Piel De Seda
The FDA is warning consumers not to purchase or use a skin whitening cream called “Crema Piel De Seda,” due to the risk of mercury poisoning. FDA laboratory analysis identified mercury in the product. Exposure to mercury can cause serious health problems, such as kidney and nervous system damage. Mercury can also interfere with brain development in children.
Learn more about Crema Piel De Seda
Olympus TJF-Q180V Duodenoscope
The FDA cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in healthcare facilities and make the needed repair as quickly as possible. Olympus modified its design of the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel. Leakage into this channel could pose an infection risk to subsequent patients exposed to the contaminated device because the sealed area cannot be cleaned and disinfected between uses.
Learn more about Olympus TJF-Q180V Duodenoscope