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FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements
August 11, 2017 -- The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby...
Monthly News Roundup - July 2017
FDA Approves Gilead’s Vosevi for Six Hepatitis C Genotypes The U.S. Food and Drug Administration (FDA) has approved Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of...
FDA Clears First Neonatal Magnetic Resonance Imaging Device
July 20, 2017 -- Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI...
Endo Provides Update On Opana ER
DUBLIN, July 6, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes...
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
July 3, 2017 -- Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in...
Monthly News Roundup - June 2017
New Fluoroquinolone Baxdela Approved for Certain Skin Infections Roughly 3 million patients are hospitalized each year in the U.S. with acute bacterial skin and skin structure infections (ABSSSIs), some of which may be difficult-to-treat and...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
June 29, 2017 -- The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas,...
FDA Unveils Plan to Eliminate Orphan Designation Backlog
June 29, 2017 -- Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm...
FDA Tackles Drug Competition to Improve Patient Access
June 27, 2017 -- Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent,...
Sonar Products Ordered to Cease Operations, Stratus Pharmaceuticals Ordered to Cease Distributing Unapproved Drugs
June 15, 2017 -- Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc....
FDA Requests Removal of Opana ER for Risks Related to Abuse
June 8, 2017 -- Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is...
FDA Approves First Generic Truvada for HIV Infection and Pre-Exposure Prophylaxis (PrEP)
June 8, 2017 - The U.S. Food and Drug Administration has approved the first generic version of Truvada for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex...
Monthly News Roundup - May 2017
Actemra: First Drug Approved to Treat Giant Cell Arteritis Actemra (tocilizumab) from Hoffman La Roche has gained a new indication as the first drug approved to treat adults with giant cell arteritis, a specific type of vasculitis. Vasculitis is...
FDA Approves First Generic Strattera for the Treatment of ADHD
May 30, 2017 -- The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Apotex Inc., Teva Pharmaceuticals...
FDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests
May 17, 2017 -- The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in...
FDA Authorizes Use of New Device to Treat Esophageal Birth Defect in Babies
May 12, 2017 -- The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their...
Monthly News Roundup - April 2017
Takeda Announces FDA Accelerated Approval of Alunbrig The US Food and Drug Administration (FDA) has approved once-daily oral Alunbrig (brigatinib) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small...
FDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients
April 7, 2017 -- The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were...
FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions
April 6, 2017 -- The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA...
FDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr
March 31, 2017 -- The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency...
Monthly News Roundup - March 2017
Ocrevus Approved for Novel Use Among Multiple Sclerosis Treatments The much anticipated multiple sclerosis (MS) treatment Ocrevus (ocrelizumab) was given the green light from the FDA this month. Ocrevus is a humanized monoclonal antibody designed...
Monthly News Roundup - February 2017
FDA Approves Once-Daily Qtern Tablets for Adults with Type 2 Diabetes The U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl...
FDA Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis
February 23, 2017 -- The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory...
FDA Allows Marketing of Test to Identify Organisms That Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results
February 23, 2017 -- The U.S. Food and Drug Administration today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about...
Louisiana Drug and Dietary Supplement Maker Ordered to Cease Operations Due to Federal Violations
February 21, 2017 -- On Friday, U.S. District Judge Robert G. James for the U.S. District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and...
Monthly News Roundup - January 2017
Trulance Cleared by FDA for Chronic Idiopathic Constipation (CIC) The U.S. Food and Drug Administration (FDA) has approved Synergy’s Trulance (plecanatide), a uroguanylin analog for the treatment of chronic idiopathic constipation (CIC)....
FDA Approves Xyrem (sodium oxybate) Oral Solution Generic with a REMS Program
January 18, 2017 -- The FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. Cataplexy is a...
Monthly News Roundup - December 2016
Biogen’s Spinraza Approved for Spinal Muscular Atrophy The U.S. Food and Drug Administration (FDA) has cleared Biogen's Spinraza (nusinersen), the first drug for spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting...
Monthly News Roundup - November 2016
Novo Nordisk’s Xultophy 100/3.6 FDA-Approved for Type 2 Diabetes This month the U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Xultophy 100/3.6 (insulin degludec and liraglutide), a once-daily injection of insulin degludec...
Monthly News Roundup - October 2016
Merck’s Zinplava Approved to Fend Off Return of Clostridium Difficile Zinplava (bezlotoxumab) has been FDA-approved to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for...
Monthly News Roundup - September 2016
Amjevita, a Biosimilar to Humira, Wins FDA Approval Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA) and is used for the treatment of seven inflammatory...
Monthly News Roundup - August 2016
FDA Approves Erelzi: Sandoz’s Biosimilar For Enbrel A third U.S. biosimilar has been FDA-approved; this time it’s Erelzi (etanercept-szzs), a biosimilar to Amgen’s tumor necrosis factor (TNF) blocker Enbrel. Sandoz’s Erelzi is the first...
FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu
On August 3, 2016, the U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have...
Kratom Seized in California by US Marshals Service
August 4, 2016 -- The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business...
Monthly News Roundup - July 2016
Injectable Adlyxin FDA-Approved for Type 2 Diabetes The FDA has approved Sanofi’s Adlyxin (lixisenatide), a new once-daily injectable type 2 diabetes medication. Adlyxin is classified as an incretin mimetic/GLP-1 receptor agonist. For...
FDA Updates Warnings for Fluoroquinolone Antibiotics
July 26, 2016 -- The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and...
FDA approves first absorbable stent for coronary artery disease
July 5, 2016 -- The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the...
Monthly News Roundup - June 2016
Epclusa: First Approval For All Major Forms of Chronic Hepatitis C Virus The U.S. Food and Drug Administration (FDA) has given the go-ahead to Epclusa (sofosbuvir and velpatasvir), a nucleotide analog polymerase inhibitor and pan-genotypic NS5A...
FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
June 29, 2016 -- The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to...
FDA approves implantable device that changes the shape of the cornea to correct near vision
June 29, 2016 -- The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second...

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