Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. announced that the FDA has approved Belbuca (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Belbuca is expected to be commercially available in the US during the first quarter of 2016 in seven dosage strengths.
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Bio Products Laboratory, Ltd. announced that the FDA has approved Coagadex for the treatment of adults and children (aged 12 years and older) with hereditary factor X deficiency for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild hereditary factor X deficiency. Coagadex is expected to be available to patients in the US in December 2015 through a network of specialty pharmacies and authorized distributors.
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Tris Pharma, Inc. announced that the FDA has approved Dyanavel XR (amphetamine), extended-release oral suspension, CII, for the treatment of attention-deficit/hyperactivity disorder in children 6 years of age and older. Dyanavel XR is expected to be available to physicians and patients in 2016.
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EarLens Contact Hearing Device (CHD)
The FDA has allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens CHD is indicated for use by adults with mild to severe sensorineural hearing impairment.
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LEO Pharma Inc. announced that Enstilar has been approved by the FDA for the topical treatment of plaque psoriasis in adults 18 years of age and older. Enstilar is a once-daily, alcohol free foam formulation in a pressurized spray can that allows application across large body areas of plaque psoriasis.
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FilmArray Meningitis/Encephalitis (ME) Panel
The FDA allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections. The FilmArray ME Panel uses CSF specimens from patients who have signs and/or symptoms of meningitis or encephalitis. It is intended as an aid in the diagnosis of those diseases when used in conjunction with other clinical and laboratory findings.
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The FDA approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
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Amgen announced that the FDA has approved the Biologics License Application for Imlygic (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
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Inspirion Delivery Technologies LLC announced that the FDA has approved MorphaBond (morphine sulfate) extended-release (ER) tablets, for oral use, CII. MorphaBond is an abuse-deterrent formulation of ER-morphine using physical and chemical barriers, without the use of aversive agents or opioid antagonists.
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GlaxoSmithKline received approval from the FDA for its Biologics License Application for Nucala (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala targets interleukin-5, which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma.
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Merrimack announced that Onivyde (irinotecan liposome injection) has been approved by the FDA in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
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Boehringer Ingelheim announced the FDA granted approval of Praxbind (idarucizumab). Praxbind is indicated for patients treated with Pradaxa (dabigatran etexilate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
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Alexion Pharmaceuticals, Inc. announced that the FDA has approved Strensiq (asfotase alfa) for the treatment of patients with perinatal-, infantile-, and juvenile-onset hypophosphatasia (HPP). Alexion will now begin serving patients with HPP in the US, with Strensiq becoming available commercially by October 27, 2015.
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Novartis announced that the FDA has approved the dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. Novartis expects that Utibron Neohaler will be available in the first quarter of 2016.
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Relypsa, Inc. announced that the FDA has approved Veltassa (patiromer) for oral suspension, a new polymer medicine that binds potassium, for the treatment of hyperkalemia. Veltassa is expected to be available to patients in the US by the first week of January 2016.
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Iroko Pharmaceuticals, LLC announced that the FDA approved Vivlodex (meloxicam) capsules, a nonsteroidal anti-inflammatory drug, for the management of osteoarthritis pain in 5mg and 10mg doses administered once daily. Vivlodex is the first FDA-approved low dose SoluMatrix meloxicam.
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Janssen Biotech, Inc. announced the FDA has approved Yondelis (trabectedin) for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
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Intelesens is proud to announce that its revolutionary, wearable, Wi-Fi connected, vital signs monitor, Zensor, which is designed specifically for monitoring patients outside of hospital, has been awarded its FDA Class II clearance to be marketed and deployed as a medical device in the US.
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Acetaminophen Tablets by Medline Industries
Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The acetaminophen 500mg, tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg.” The acetaminophen tablets, 500mg is incorrectly labeled as 325mg tablets.
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Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15mg and 0.3mg strengths for hospitals, retailers, and consumers. This includes lot numbers 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.
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Beacon Tip Angiographic Catheters
Cook Medical initiated a voluntary recall for select sizes of Beacon Tip Angiographic Catheters. This recall includes all lots of these select sizes of the Beacon Tip Angiographic Catheters. This recall is an expansion of the voluntary lot-specific recall issued on July 2, 2015. The products include specific versions of the Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, Slip-Cath Beacon Tip Hydrophilic Catheters, and Shuttle Select Slip-Cath Catheters.
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Downing Labs, LLC Sterile Compounded Products
Downing Labs, LLC is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs, LLC and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015.
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Myocardial Protection System (MPS) Delivery Set
Quest Medical, Inc. initiated a nationwide recall of MPS Delivery Sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The product(s) have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss. Recalled product(s) were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.
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Sterile Drug Products from Qualgen
The FDA is alerting healthcare professionals and patients about a voluntary recall of lots 1 through 67 of non-expired drug products intended to be sterile produced and distributed nationwide by Qualgen LLC, due to lack of sterility and quality assurance. The recalled products were compounded prior to September 1, 2015.
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Through analysis of adverse event reports, the medical literature, and information from national and international public health agencies, the FDA is aware that the use of heater-cooler devices has been associated with nontuberculous mycobacteria infections, primarily in patients undergoing cardiothoracic surgical procedures. Between January 2010 and August 2015, the FDA received 32 medical device reports of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination.
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The FDA is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth–drug interactions that could affect how well the other medications work.
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Viekira Pak and Technivie
The FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, the FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
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