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FDA Requests Removal of Opana ER for Risks Related to Abuse
Posted 2 weeks ago in Pharma Industry News
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 seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of...
Read moreFDA Approves First Generic Truvada for HIV Infection and Pre-Exposure Prophylaxis (PrEP)
Posted 3 weeks ago in Pharma Industry News
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 practices to prevent sexually-acquired HIV infection in adults at high risk. PrEP may be part of a comprehensive HIV prevention strategy that includes safer sex practices, such as consistent and correct condom use, regular HIV testing and risk...
Read moreMonthly News Roundup - May 2017
Posted 4 weeks ago in Pharma Industry News
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 a group of disorders that leads to swelling of blood vessels. In a clinical study of 251 patients with giant cell arteritis, the primary endpoint, defined as the proportion of patients achieving sustained remission from Weeks 12 to 52, was met....
Read moreFDA Approves First Generic Strattera for the Treatment of ADHD
Posted 4 weeks ago in Pharma Industry News
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 USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited today gained approval to market atomoxetine in multiple strengths. "Today’s approvals mark an important step forward in bringing consumers additional treatments that have met t...
Read moreFDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests
Posted 6 weeks ago in Pharma Industry News
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 the United States. The CDC recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they...
Read moreFDA Authorizes Use of New Device to Treat Esophageal Birth Defect in Babies
Posted 6 weeks ago in Pharma Industry News
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 esophagus, called esophageal atresia. An estimated 1 in every 2,500 babies in the U.S. is born with esophageal atresia. Babies with this condition cannot feed normally, and they require a feeding tube until surgery can be performed to attach the...
Read moreMonthly News Roundup - April 2017
Posted 8 weeks ago in Pharma Industry News
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 cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). In the pivotal Phase 2, open-label ALTA study which enrolled 222 patients, the overall response rate after a median follow up of 8 months at the recommended...
Read moreFDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients
Posted 11 weeks ago in Pharma Industry News
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 previously approved to treat HCV in adults. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from...
Read moreFDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions
Posted 11 weeks ago in Pharma Industry News
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 that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional. “Consumers can now have ...
Read moreFDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr
Posted 12 weeks ago in Pharma Industry News
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 treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distr...
Read moreMonthly News Roundup - March 2017
Posted 12 weeks ago in Pharma Industry News
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 to selectively target CD20-positive B cells. It is the first treatment approved for primary progressive multiple sclerosis (PPMS); it’s also indicated for relapsing (RMS). In both forms of MS, Phase III studies demonstrated that Ocrevus slowed d...
Read moreMonthly News Roundup - February 2017
Posted 17 weeks ago in Pharma Industry News
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 peptidase-4 (DPP4) inhibitor treatment for adults with type 2 diabetes. This new combination agent is to be used alongside diet and exercise in those without adequate blood sugar control with dapagliflozin or who are already treated with dapagliflozin ...
Read moreFDA Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis
Posted 17 weeks ago in Pharma Industry News
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 tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with the body’s response to a bacterial infection, as a biomarker to help make a...
Read moreFDA Allows Marketing of Test to Identify Organisms That Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results
Posted 17 weeks ago in Pharma Industry News
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 which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it takes to provide this important information, which can guide antibiotic treatment recommendations more quickly. "By...
Read moreLouisiana Drug and Dietary Supplement Maker Ordered to Cease Operations Due to Federal Violations
Posted 18 weeks ago in Pharma Industry News
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 distributor of drugs and dietary supplements, and its owner, Anton S. Botha, requiring the business to immediately cease operations until it comes into compliance with federal laws. The complaint, filed by the U.S. Department of Justice, sought a...
Read moreMonthly News Roundup - January 2017
Posted 21 weeks ago in Pharma Industry News
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). Trulance works by stimulating secretion of bowel fluids. In studies, participants randomly received either 3 or 6 milligram (mg) Trulance tablets once a day for 12 weeks, or placebo. Those receiving Trulance had improvements in the frequency of complete s...
Read moreFDA Approves Xyrem (sodium oxybate) Oral Solution Generic with a REMS Program
Posted 23 weeks ago in Pharma Industry News
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 primary symptom of narcolepsy where patients suddenly lose muscle tone, including voluntary muscle control, while awake. Muscle weakness or paralysis associated with cataplexy may cause a person to collapse. Approximately 70 percent of people with...
Read moreMonthly News Roundup - December 2016
Posted 25 weeks ago in Pharma Industry News
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 muscle strength and movement. Spinraza is classified as a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide and alters the splicing of the SMN2 gene to yield a more functional protein. In an interim analysis of efficacy, 40% of patients t...
Read moreMonthly News Roundup - November 2016
Posted 30 weeks ago in Pharma Industry News
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 (Tresiba), and the glucagon-like peptide-1 (GLP-1) agonist liraglutide (Victoza), used with diet and exercise to improve blood sugar control in type 2 diabetes. Xultophy is used in adults inadequately controlled on less than 50 units of basal insulin daily ...
Read moreMonthly News Roundup - October 2016
Posted 34 weeks ago in Pharma Industry News
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 CDI and who are at high risk for CDI recurrence. Zinplava is not an antibacterial and does not treat an active CDI infection. Zinplava is a human monoclonal antibody that binds with C. difficile toxin B to prevent its effects on human cells. Common a...
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