FDA New Approvals
Amgen has announced that the FDA has granted approval of Corlanor (ivabradine), an oral medication indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤35%, who are in sinus rhythm with resting heart rate ≥70 beats per minute, and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.
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The Medicines Company announced that the FDA has approved Ionsys (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital.
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The FDA has approved the Kamra inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery.
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Kythera Biopharmaceuticals, Inc. announced that the FDA has approved Kybella, also known as ATX-101, “for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.” Kybella is the first and only approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition.
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The Medicines Company announced that the FDA has approved Raplixa (fibrin sealant) and the RaplixaSpray device to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
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Vernalis and Tris Pharma Inc. announced that the FDA has approved the New Drug Application for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III). Tuzistra XR is an extended-release oral suspension combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years and older.
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FDA New Indications
Actavis has announced that the FDA has approved an expansion of the Botox (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus (a muscle in the forearm that flexes the thumb) and adductor pollicis (a muscle in the hand that functions to adduct the thumb), increasing the maximum dose from 360 to 400 units for the treatment of upper limb spasticity. The FDA also approved an increase to the maximum Botox cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
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GlaxoSmithKline and Theravance, Inc. have announced that the FDA has approved Breo Ellipta (fluticasone furoate/vilanterol) for the once-daily treatment of asthma in patients aged 18 years and older. Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once daily using the Ellipta dry powder inhaler.
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Eli Lilly and Company has received its fourth FDA approval for Cyramza (ramucirumab). Cyramza is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
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FDA First-Time Generic Approvals
The FDA has approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals, and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.
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Sandoz, a Novartis company, has announced the US approval of Glatopa, the first generic version of Teva’s Copaxone (glatiramer acetate injection) 20mg/mL one-time-daily multiple sclerosis therapy.
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FDA Labeling Changes
Medicure Inc. ("Medicure" or the "Company") announced that the FDA has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus regimen. The dosing change and label modification was requested by the Company to help healthcare professionals more efficiently meet patient-specific administration needs and to optimize the implementation of Aggrastat at new hospitals. The newly approved labeling supplement now allows the delivery duration of the Aggrastat high-dose bolus (25mcg/kg) to occur anytime within 5 minutes, instead of the previously specified duration of 3 minutes.
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Celgene Corporation has announced it has fulfilled the accelerated approval requirements for Pomalyst (pomalidomide) based on results from MM-003, an international phase III study of Pomalyst plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma patients. Pomalyst, in combination with dexamethasone, is approved for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
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FDA New Formulations
The Medicines Company announced that the FDA has approved a supplemental new drug application for a new formulation of Minocin (minocycline) for Injection. The FDA has also granted Qualified Infectious Disease Product designation for the new formulation of Minocin for Injection under the Generating Antibiotic Incentives Now Act (GAIN Act).
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Teva Parenteral Medicines announced a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5g/100mL (50mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
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Baxter IV Solutions
Baxter International Inc. announced it is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. IV administration of a solution containing sterile particulate matter may lead to adverse health consequences. The lots being recalled were distributed to customers and distributors in the US and Bermuda between January 14, 2015 and March 5, 2015.
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Bupivacaine HCl Injection
Hospira, Inc. has announced it is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5mg/mL), 30mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. The lot was distributed from July 2014 to September 2014.
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Ebola Virus One-Step Test Kits
All lots of the Ebola Virus One-Step Test kits are affected by this recall. The affected devices were sold in California and exported internationally to Sierra Leone, Canada, and Denmark between October 2014 and January 2015. The FDA has not cleared or approved the Ebola Virus One-Step Test Kits for use or sale. The results obtained from these test kits have not demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection.
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GlaxoSmithKline (GSK) is voluntarily recalling all remaining lots of 2014–2015 Flulaval quadrivalent Thimerosal-Free Pre-Filled Syringes. As part of stability testing, GSK observed loss of potency below the minimum specification prior to product expiry for the B strains included in the vaccine. The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concern. This recall does not affect Flulaval Quadrivalent Multi Dose Vials (MDV), Flulaval [trivalent] MDV, or any other GSK vaccines.
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Mucinex Fast-Max Products
RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-Max Night Time Cold & Flu; Mucinex Fast-Max Cold & Sinus; Mucinex Fast-Max Severe Congestion & Cough, and Mucinex Fast-Max Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and list all active ingredients, may not have the correct corresponding drug facts label on the back. This recall was due to a confirmed report from a retailer. This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients, including acetaminophen, dextromethorphan, guaifenesin, phenylephrine, and/or diphenhydramine.
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Mylan Injectable Products
Mylan N.V. has announced that its US-based Mylan Institutional business is conducting a voluntary nationwide recall to the hospital/user level of select lots of injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples. Gemcitabine for Injection, USP 200mg lots were distributed in the US between February 18, 2014 and December 19, 2014. Carboplatin Injection 10mg/mL lot was distributed in the US between August 11, 2014 and October 7, 2014. Methotrexate Injection, USP 25mg/mL lot was distributed in the US between January 16, 2014 and March 25, 2014. Cytarabine Injection lot was distributed in the US between May 02, 2014 and July 24, 2014.
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Standardized Meadow Fescue Grass Pollen Allergenic Extract
Greer Laboratories, Inc., is initiating a voluntary recall for Standardized Meadow Fescue (Festuca elatior) Grass Pollen Allergenic Extract, 1000,000 BAU/ML manufactured and distributed by Antigen Laboratories, Inc. The product is being recalled because ongoing stability evaluations indicate a decrease in potency for this lot. Consignees are asked to discontinue use of this product and contact Greer to arrange for product return.
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VV13F Reinforced Dual Lumen ECMO Catheters
OriGen Biomedical has initiated a nationwide recall for one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters. These VV13F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage. OriGen VV13F Reinforced Dual Lumen ECMO Catheters manufactured on September 22, 2014 and distributed from February 16 to March 26, 2015 have been recalled.
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Bo Ying Compound
The FDA is working with the Maryland Department of Health and Mental Hygiene (DHMH) and other states to continue to warn consumers and caregivers not to use Eu Yan Sang (Hong Kong) Ltd.’s “Bo Ying compound” because of the possible lead poisoning risk associated with the product. This reminder comes after Maryland’s DHMH found elevated levels of lead in these products. The powdered product is marketed in retail outlets and online for use in infants and children for treatment of a variety of conditions, including influenza, fever, sneezing, and nasal discharge. The product is labeled in Chinese and English.
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Counterfeit Botox Found in the US
The FDA is alerting healthcare practitioners and the public that a counterfeit version of Botox was found in the US and may have been sold to doctors’ offices and medical clinics nationwide. The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the US. The counterfeit products are considered unsafe and should not be used.
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Flurbiprofen-Containing Topical Pain Medications
The FDA is alerting pet owners, veterinarians, healthcare providers, and pharmacists that pets are at risk of illness and death when exposed to topical pain medications containing the NSAID flurbiprofen. People using these medications should use care when applying them in a household with pets, as even very small amounts could be dangerous to these animals.
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Mammograms at Coastal Diagnostic Center
The FDA is alerting patients who had mammograms at Coastal Diagnostic Center, located in Pismo Beach, California, anytime on or after February 24, 2013, about possible problems with the quality of their mammograms. This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms reevaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up.
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Mammograms at J. Bruce Jacobs M.D., Inc.
The FDA is alerting patients who had mammograms at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology, located in Huntington Park, California, anytime on or after September 8, 2014, about possible problems with the quality of their mammograms. This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms reevaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up.
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The FDA is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury. Tri-Methyl Xtreme, distributed by Las Vegas-based Extreme Products Group, claims to contain anabolic steroids and is sold on the Internet and in some retail stores and gyms. An investigation is underway by the FDA to identify the product’s manufacturer after the agency received adverse event reports from consumers—one each from California, New Jersey, and Utah. The agency has not received reports of death from use of the product.
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US Marshals Seize Unapproved Drugs from Florida Distributor
At the request of the FDA and the US Attorney for the Southern District of Florida, US Marshals have seized unapproved prescription drug products valued at over $16 million from Stratus Pharmaceuticals, Inc. Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc. The seized products include a solution used to treat excessive sweating; an antibiotic cleanser for treatment of skin conditions, such as acne, rosacea, and seborrhea; a topical ointment used to treat wounds; a topical cream and gel to treat psoriasis, eczema, and other skin conditions; and analgesic eardrops used to treat ear pain.
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