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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...
FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX
June 9, 2016 -- The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved...
FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
June 1, 2016 -- The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can...
Monthly News Roundup - May 2016
FDA Approves Zinbryta for Multiple Sclerosis Multiple sclerosis, a chronic, inflammatory, autoimmune disease of the central nervous system, has been reported as the leading cause of disability in young adults 20 to 40 years of age. The US Food...
FDA takes significant steps to protect Americans from dangers of tobacco through new regulation
May 5, 2016 -- Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the...
FDA reminds health care professionals not to use drug products intended to be sterile from Medaus
May 5, 2016 -- The U.S. Food and Drug Administration is reminding health care professionals and patients not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The FDA has issued a formal...
FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults
May 2, 2016 -- The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults ages 18-24. Of the...
Monthly News Roundup - April 2016
First-Time Generic Approved for Statin Crestor High cholesterol, high low-density lipoprotein (LDL) or “bad cholesterol”, and triglycerides increase the risk for serious heart disease and may lead to heart attacks and strokes. The FDA has now...
FDA Approves First Generic Crestor
April 29, 2016 -- The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses: in combination with diet for the treatment of high triglycerides...
FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior
April 22, 2016 - The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health...
FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens
April 19, 2016 -- The U.S. Food and Drug Administration announced today it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco...
FDA approves folic acid fortification of corn masa flour
April 14, 2016 -- The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with...
FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns
April 8, 2016 -- Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a...
Monthly News Roundup - March 2016
FDA Approves Teva’s Cinqair to Treat Severe Asthma In March, the U.S. Food and Drug Administration (FDA) approved Teva’s Cinqair (reslizumab) as an adjunct for the maintenance treatment of severe asthma in adults not well-controlled on their...
FDA allows use of investigational test to screen blood donations for Zika virus
March 30, 2016 -- The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for...
FDA takes important step to increase the development of, and access to, abuse-deterrent opioids
March 24, 2016 -- The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF...
FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death
March 22, 2016 -- In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release...
CDC Releases Guideline for Prescribing Opioids for Chronic Pain
March 15, 2016 -- As part of the U.S. government’s urgent response to the epidemic of overdose deaths, the Centers for Disease Control and Prevention (CDC) today is issuing new recommendations for prescribing opioid medications for chronic pain,...
FDA Alerts Healthcare Professionals About Clinical Trials with Zydelig (idelalisib) in Combination with other Cancer Medicines
March 14, 2016 -- The U.S. Food and Drug Administration is alerting health care professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination...
FDA Approves First Generic Viagra (sildenafil citrate) for Erectile Dysfunction
March 9, 2016 -- Today, the U.S. Food and Drug Administration approved the first generic version of Viagra (sildenafil citrate), for the treatment of erectile dysfunction. Teva Pharmaceutical Industries received approval to market generic...
FDA takes additional action to better understand safety of Essure, inform patients of potential risks
February 29, 2016 -- The U.S. Food and Drug Administration announced today actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with...
Monthly News Roundup - February 2016
Briviact Wins FDA Approval As Adjunct for Partial Onset Seizures Epilepsy is a brain disorder that causes people to have recurring seizures, consisting of uncontrollable muscle movements, abnormal sensations or thinking. The U.S. Food and Drug...

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