FDA New Approvals
Actavis announced the FDA has approved Avycaz (ceftazidime-avibactam). Avycaz was approved for the treatment of adult patients with complicated intra-abdominal infections (in combination with metronidazole) and complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. Avycaz will be available in the second quarter of 2015.
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Bloom Syndrome Carrier Test
The FDA authorized for marketing 23andMe’s Bloom syndrome carrier test, a direct-to-consumer genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder.
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The FDA has approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections. Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell wall of a fungus. Cresemba is available in oral and intravenous formulations.
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The FDA allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women. The Eclipse System is intended to treat FI in women 18 to 75 years old who have had four or more FI episodes in a two-week period. The device includes an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of FI episodes.
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Enroute Transcarotid Neuroprotection System
The FDA has cleared for marketing the Enroute Transcarotid Neuroprotection System, for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.
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Novartis announced that the FDA has approved Farydak (panobinostat, previously known as LBH589) capsules in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent.
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Finafloxacin Otic Suspension
MerLion Pharmaceuticals announced that an otic suspension of finafloxacin has been approved by the FDA to treat acute otitis externa (commonly known as "swimmer’s ear") caused by Pseudomonas aeruginosa and Staphylococcus aureus.
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Eisai Inc. announced that the FDA approved the company's receptor tyrosine kinase inhibitor Lenvima (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvima will be available to order in the near future through specialty pharmacies Biologics, Inc. and Accredo.
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Actavis and Medicines360 announced the approval of Liletta (levonorgestrel-releasing intrauterine system) by the FDA for use by women to prevent pregnancy for up to three years. Liletta is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy. Actavis and Medicines360 expect that Liletta will be available for use in the US by Q2 2015.
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Bristol-Myers Squibb Company announced that the FDA has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
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Sanofi announced that the FDA approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the US at the beginning of Q2 2015.
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VenaSeal Closure System
The FDA approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. The VenaSeal system is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes.
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The FDA approved Zarxio (filgrastim-sndz) Injection, as a biosimilar to US-licensed Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a healthcare professional for: patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.
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FDA First-Time Generic Approvals
Pharma Major Lupin Limited (Lupin) announced that it has received final approval for its Bimatoprost Ophthalmic Solution, 0.03% from the FDA to market a generic version of Allergan Inc.’s Lumigan Ophthalmic Solution, 0.03%. Lupin Pharmaceuticals Inc., the company’s US subsidiary, would commence marketing the product shortly. Lupin's Bimatoprost Ophthalmic Solution, 0.03% is the AT rated generic equivalent of Lumigan Ophthalmic Solution, 0.03% and is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
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Actavis announced that it has received final approval from the FDA on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (buprenorphine 2mg and 8mg sublingual tablets). Actavis intends to begin shipping its product shortly.
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FDA New Indications
Eisai Co., Ltd. announced that its US subsidiary Eisai Inc. has received approval of an additional pediatric indication for Eisai's antiepileptic drug Banzel (rufinamide) from the FDA. Through this approval, Banzel, which had been approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children four years older and adults, is now additionally approved for the same indication in pediatric patients from one to less than four years of age in the US.
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Meda announces the FDA approval of Dymista, a single formulation azelastine hydrochloride and fluticasone propionate nasal spray for the relief of symptoms of seasonal allergic rhinitis (SAR) in patients 6 to 11 years of age who require treatment with both components. Dymista was previously indicated only for adults and children 12 and older. The approved dosing for Dymista in children 6 to 11 is 1 spray/nostril bid (same as the dosing for adolescents and adults with SAR).
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Roche announced that the FDA approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy, in people with diabetic macular edema (DME). In 2012, Lucentis was approved by the FDA for the treatment of DME. Lucentis has also been an option for patients with wet age-related macular degeneration since 2006 and macular edema following retinal vein occlusion since 2010.
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Celgene Corporation announced that the FDA has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Revlimid plus dexamethasone was previously approved in June 2006 for use in multiple myeloma patients who have received at least one prior therapy.
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Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility. The lot numbers being recalled are VATA012, VATA015 (50mg/5mL) and VATB012, VATB013, VATB014, VATB017 (100mg/10mL) which were distributed to hospitals, wholesalers, and distributors nationwide from February 2014 through February 2015.
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Colistimethate for Injection USP, 150mg and Rifampin for Injection USP, 600mg/vial
Heritage Pharmaceuticals Inc. announced the voluntary nationwide recall of ten lots of Colistimethate for Injection, USP, 150mg Single-Dose vial (NDC 23155-193-31) and three lots of Rifampin for Injection, USP, 600mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten. Heritage has initiated this voluntary recall of Colistimethate for Injection, USP, 150mg Single-Dose vial and Rifampin for Injection USP, 600mg Single-Dose vial to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer's site potentially impacting product sterility. The products were distributed to hospitals, wholesalers, and distributors nationwide from December 2012 through January 2015 (Colistimethate) and from October 2014 through January 2015 (Rifampin).
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Detox Transforms Health and Nutrition Dietary Supplements
Detox Transforms Health and Nutrition announced it is conducting a voluntary recall of select dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs. FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended. Any adverse reaction that is possible with fluoxetine is possible with the fluoxetine-containing dietary supplement product. FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil, which has the potential to interact with medications.
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HeartWare Ventricular Assist System Controllers
HeartWare International, Inc. is issuing a voluntary Urgent Medical Device Recall in the US related to older HeartWare Ventricular Assist System Controllers, which were distributed in the US during the clinical trial period prior to FDA approval in 2012. The company advises that affected clinical trial controllers exhibit a higher susceptibility to electrostatic discharge than newer, commercial controllers. This recall of HeartWare controllers (product codes 1400 and 1401XX) distributed during the ADVANCE and ENDURANCE clinical trial periods with Serial Numbers CON000001 through CON005472 is an expansion of HeartWare’s voluntary Field Safety Corrective Action, APR2013.
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Ketorolac Tromethamine Injection
Hospira, Inc. has announced a voluntary recall of ketorolac tromethamine injection, USP in the US and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials. The particulate was identified as calcium-ketorolac crystals. Multiple lots are impacted by this recall.
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Magnesium Sulfate in 5% Dextrose
Hospira, Inc., has announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP units/1000mL in 0.9% Sodium Chloride Inj. The product is labeled with the correct printed name on the primary container and overwrap.
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Maquet Servo Humidifier 163
Two recalls have been issued for the Teleflex Medical, Maquet Servo Humidifier 163 for connector cracks and cracks in connector tubes. Some connector cracks were found when preparing patients for support with a ventilator. These cracks may lead to oxygen and other gases leaking from the ventilator and not delivering sufficient treatment to patients, potentially causing serious injury or death. Also, cracks were found in the connector tubes during the manufacturing process and some devices were distributed before the problem was identified.
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MRI Systems with Magnet Rundown Unit
Some MRI units may have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit (MRU). The MRU is one method used to shut off the magnetic field of the MRI in case of an emergency, such as when a metal (ferrous) object is brought into the magnetic field. In such an emergency situation, a delay in shut off can potentially result in life-threatening injuries. There were two reported injuries when hospital employees entered the MRI room carrying a metal container.
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Trellis 6 and Trellis 8 Peripheral Infusion Systems
The Trellis 6 and Trellis 8 Peripheral Infusion systems are used to treat blood clots that may form in the veins or arteries of the arms, hands, legs, or feet. A manufacturing error caused the balloon inflation ports to be mislabeled. This may cause the physician using the device to deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.
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0.9% Sodium Chloride Injection, USP, 250mL VisIV Container
Hospira, Inc. announced that it will initiate a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry 1MAR2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
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Endoscopic Retrograde Cholangiopancreatography Duodenoscopes
The FDA wants to raise awareness among healthcare professionals, including those working in reprocessing units in healthcare facilities, that the complex design of endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by carbapenem-resistant Enterobacteriaceae such as Klebsiella species and Escherichia coli.
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Multi-Dose Diabetes Pen Devices
In an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only, the FDA is requiring additional label warnings prohibiting sharing of these injectable medicines. Insulin pens and pens for other injectable diabetes medicines should never be shared among patients, even if the needle is changed. Sharing pens can result in the spread of serious infections from one patient to another. To promote safe use, the FDA is requiring that pens and packaging containing multiple doses of insulin and other injectable diabetes medicines display a warning label stating "For single patient use only."
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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. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.
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