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Monthly News Roundup - August 2016
Posted 3 weeks ago in Pharma Industry News
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 approved biosimilar for etanercept, and is used for the same five indications found on the reference product Enbrel: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It’s impo...
Read moreFDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu
Posted 7 weeks ago in Pharma Industry News
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 had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999. The FDA is committed to improving patient access to safe and effective generic drugs. Generic drugs...
Read moreKratom Seized in California by US Marshals Service
Posted 7 weeks ago in Pharma Industry News
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 as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000. The U.S. Department of Justice filed the complaint, on behalf of the FDA, in...
Read moreMonthly News Roundup - July 2016
Posted 8 weeks ago in Pharma Industry News
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 maintenance dosing, Adlyxin will be available in a disposable pre-filled pen of 20 micrograms. Adlyxin is given at mealtime and used alongside diet and exercise to improve blood sugar levels. In clinical studies, Adlyxin met the primary endpoint of hemoglobin A...
Read moreFDA Updates Warnings for Fluoroquinolone Antibiotics
Posted 8 weeks ago in Pharma Industry News
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 to limit their use in patients with less serious bacterial infections. “Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center fo...
Read moreFDA approves first absorbable stent for coronary artery disease
Posted 11 weeks ago in Pharma Industry News
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 growth of scar tissue, is gradually absorbed by the body in approximately three years. “The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rat...
Read moreMonthly News Roundup - June 2016
Posted 12 weeks ago in Pharma Industry News
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 inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) infection in adults. Epclusa is used for HCV genotypes 1 through 6, with or without cirrhosis. In studies, 95 to 99 percent of Epclusa-treated patients without...
Read moreFDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
Posted 12 weeks ago in Pharma Industry News
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 Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states...
Read moreFDA approves implantable device that changes the shape of the cornea to correct near vision
Posted 12 weeks ago in Pharma Industry News
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-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision. Presbyopia is the loss of the...
Read moreFDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX
Posted 15 weeks ago in Pharma Industry News
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 prescription drugs to U.S. consumers. This effort was part of Operation Pangea IX, the Ninth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and...
Read moreFDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
Posted 16 weeks ago in Pharma Industry News
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 detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC). Lung cancer is the leading cause of cancer-related...
Read moreMonthly News Roundup - May 2016
Posted 16 weeks ago in Pharma Industry News
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 and Drug Administration (FDA) has now approved AbbVie and Biogen’s Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta, a humanized monoclonal antibody, is a long-acting injection that is self- a...
Read moreFDA takes significant steps to protect Americans from dangers of tobacco through new regulation
Posted 20 weeks ago in Pharma Industry News
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 bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco...
Read moreFDA reminds health care professionals not to use drug products intended to be sterile from Medaus
Posted 20 weeks ago in Pharma Industry News
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 request to the Birmingham, Alabama, compounding pharmacy to recall all non-expired lots of drug products intended to be sterile. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening...
Read moreFDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults
Posted 20 weeks ago in Pharma Industry News
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 more than 2 million LGBT young adults in the U.S., more than 800,000 smoke occasionally. The “This Free Life” campaign is designed to specifically reach the occasional or “social” smokers in the LGBT community to help prevent tobacco-related disease a...
Read moreMonthly News Roundup - April 2016
Posted 21 weeks ago in Pharma Industry News
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 approved the first generic version for Crestor, known by the generic name of rosuvastatin. Rosuvastatin was approved for three uses: high triglycerides in addition to diet; primary dysbetalipoproteinemia (improper breakdown of cholesterol and tri...
Read moreFDA Approves First Generic Crestor
Posted 21 weeks ago in Pharma Industry News
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 (hypertriglyceridemia) in adults; in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides; either alone or in combination...
Read moreFDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior
Posted 22 weeks ago in Pharma Industry News
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 that cannot be corrected or eliminated through changes to the labeling. The FDA takes the act of banning a device only on rare occasions when it is necessary to protect public health. ESDs administer electrical shocks through electrodes attached...
Read moreFDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens
Posted 22 weeks ago in Pharma Industry News
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 use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highlighted through the placement of advertisements in 35 U.S. markets specifically s...
Read moreFDA approves folic acid fortification of corn masa flour
Posted 23 weeks ago in Pharma Industry News
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 the levels of certain other enriched cereal grains. Folic acid, a synthetic form of folate, is a B vitamin that when taken by a pregnant woman may help prevent neural tube defects, which are birth defects affecting the brain, spine, and spinal...
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