FDA New Approvals
Exelixis, Inc. announced that the FDA has approved Cabometyx (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
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Acadia Pharmaceuticals Inc. announced that the FDA has approved Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Acadia plans to make Nuplazid commercially available to patients in the United States in June 2016.
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AbbVie announced the FDA has granted accelerated approval of Venclexta (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group.
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FDA First-Time Generic Approvals
First Generic Version of Crestor
Allergan confirmed that it has received final approval from the FDA on its Abbreviated New Drug Application for rosuvastatin calcium 5, 10, 20, and 40mg tablets, the generic version of AstraZeneca's Crestor (rosuvastatin) tablets.
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3rd Degree, Black Gold X Advanced, and Black Label X Capsules
Making It A Lifestyle, L.L.C. is voluntarily recalling all lots of 3rd Degree, Black Gold X Advanced, and Black Label X capsule form supplements to the consumer level. The products have been found to contain undeclared sibutramine and sildenafil. These undeclared ingredients make these products an unapproved new drug for which safety and efficacy have not been established. The recalled products were distributed from February 2015 to April 27, 2016.
Learn more about 3rd Degree, Black Gold X Advanced, and Black Label X Capsules
50% Magnesium Sulfate Injection
Hospira, Inc. is voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10g/20mL (0.5g/mL), 20mL single-dose vials, Lot 50-343-DK, Expiration 01FEB2017, NDC 0409-2168-02, to the hospital level, due to a confirmed customer complaint for the presence of particulate matter, within one single-dose fliptop vial. A recall was previously executed for this lot on March 23, 2016 due to a confirmed high out-of-specification result for pH.
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Beacon Tip Technology Catheters
On April 15, 2016, Cook Medical initiated a voluntary recall of 4,146,309 catheters with Beacon Tip technology. Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which have resulted in 30 Medical Device Reports to date. This recall includes all lots of catheters with the Beacon Tip technology.
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Dialog+ Hemodialysis Systems
B. Braun Medical Inc. is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood. The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death. The recalled products include model numbers 710200L, 710200K, 710200S, 710200U, 710500L, and 710500K. The recalled products were manufactured from April 1, 2013 to July 3, 2013 and distributed from June 25, 2013 to October 7, 2015.
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Fetch 2 Aspiration Catheter
Boston Scientific has initiated a global, voluntary recall of all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled due to complaints of shaft breakage. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016.
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Pharmakon Sterile Drug Products
Pharmakon issued a voluntary nationwide recall of all sterile compounded products. All recalled products have a label that includes the Pharmakon Pharmaceuticals name, address, and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.
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PharMEDium Sterile Preparations
PharMEDium Services, LLC is voluntarily recalling the codes/lots of sterile preparations compounded with a single recalled lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) to the hospital level. Fresenius Kabi recalled the specific lot at issue due to identification of particulate matter, characterized as glass, during reserve sample inspection.
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Fresenius Kabi USA announced today that it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5mg/mL, 30mL fill in a 30mL vial. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company during inspection of reserve samples. The recalled product is labeled with Product Code 470237 and Lot Number 6111504. The product was shipped in the United States to wholesaler and distributor outlets between March 4, 2016 and March 21, 2016 and has an expiration date of September 2019. The NDC for this product is 63323-472-37.
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Super Herbs is voluntarily recalling all bottles of Super Herbs, light green and dark green capsules to the consumer level after FDA laboratory testing found Super Herbs to contain sibutramine, desmethylsibutramine, and/or phenolphthalein. The product is used as a weight loss dietary supplement and is packaged in clear bottles with light green and dark green capsules. The affected Super Herbs product includes all bottles that have been distributed nationwide to consumers via internet.
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The FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized. Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk the FDA identified. In addition, the FDA has become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, the FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.
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The FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016. No other changes will be made to the label or packaging, and the medicine is exactly the same.
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The FDA is continuing to work with clozapine manufacturers to develop a timeline for the full implementation of the shared Clozapine REMS Program, including the pre-dispense authorization and prescriber and pharmacy certification requirements. This will be completed in a phased approach beginning in May of 2016. The goal is to have the REMS fully operational by the end of 2016.
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The FDA is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. The FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete.
Learn more about Fluconazole (Diflucan)
Focus Diagnostics Laboratory Examination Kits
Focus Diagnostics is recalling Simplexa Herpes Simplex Virus 1 & 2
Direct and Simplexa Group A Strep Direct kits containing the Direct
Amplification Discs, due to poor lamination between the sample reaction wells.
This poor lamination may lead to leakage into adjacent wells causing
cross-contamination between samples, which could yield false positive, false
negative, or invalid test results. Inaccurate diagnostic test results may lead
to improper patient treatment for herpes simplex virus or group A Streptococcus and may cause serious adverse health
consequences, including death. The affected model numbers are MOL2150, MOL1451,
MOL1452, MOL2850, and MOL1455. The recalled kits were manufactured from July
30, 2015 to February 11, 2016 and distributed from September 16, 2015 to
February 11, 2016.
Learn more about Focus Diagnostics Laboratory Examination Kits
G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers
Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected. Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death, as the auditory alarm may not sound and users might not be notified of low or high blood sugar. Recalled devices include (all model numbers and all lot numbers): Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receive, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share, Dexcom G5 Mobile Receiver.
Learn more about G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers
Guardian II Hemostasis Valves
Vascular Solutions, Inc. initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. The recalled products are specific lots of Model Numbers 8210 and 8211. The products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. The recalled products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016. This recall only affects the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves.
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The FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally.
Learn more about Metformin