Skip to Content

Pharmaceutical Industry News

FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

Posted 3 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 more

FDA reminds health care professionals not to use drug products intended to be sterile from Medaus

Posted 3 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 more

FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults

Posted 3 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 more

Monthly News Roundup - April 2016

Posted 4 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 more

FDA Approves First Generic Crestor

Posted 4 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 more

FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

Posted 5 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 more

FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens

Posted 5 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 more

FDA approves folic acid fortification of corn masa flour

Posted 6 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...

Read more

FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns

Posted 7 weeks ago in Pharma Industry News

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 carcinogenic residue. CVM’s action comes after the center recently reexamined the safety profile of the drug and conducted a preliminary risk characterization that indicated there could be potential risk to human health from ingesting pork, especially pork liv...

Read more

Monthly News Roundup - March 2016

Posted 8 weeks ago in Pharma Industry News

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 current asthma medications. Cinqair is an interleukin 5 (IL-5) antagonist monoclonal antibody (IgG4 kappa) given once every four weeks via infusion in a clinical setting. In studies, patients receiving Cinqair had fewer attacks, a longer time to first att...

Read more

FDA allows use of investigational test to screen blood donations for Zika virus

Posted 8 weeks ago in Pharma Industry News

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 screening donated blood in areas with active mosquito-borne transmission of Zika virus. “The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood sup...

Read more

FDA takes important step to increase the development of, and access to, abuse-deterrent opioids

Posted 9 weeks ago in Pharma Industry News

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 opioids are no less abuse-deterrent than the brand-name drug. Today’s actions are among a number of steps the agency recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing ...

Read more

FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death

Posted 9 weeks ago in Pharma Industry News

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 (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to r...

Read more

CDC Releases Guideline for Prescribing Opioids for Chronic Pain

Posted 10 weeks ago in Pharma Industry News

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, excluding cancer, palliative, and end-of-life care. The CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016 will help primary care providers ensure the safest and most effective treatment for their patients. The United States i...

Read more

FDA Alerts Healthcare Professionals About Clinical Trials with Zydelig (idelalisib) in Combination with other Cancer Medicines

Posted 10 weeks ago in Pharma Industry News

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 with other cancer medicines. Gilead Sciences, Inc. has confirmed that they are stopping six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas. The FDA is reviewing the findings...

Read more

FDA Approves First Generic Viagra (sildenafil citrate) for Erectile Dysfunction

Posted 11 weeks ago in Pharma Industry News

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 sildenafil citrate tablets in 25 mg, 50 mg, and 100 mg strengths and has 180-day exclusivity. For information about the availability of these products, contact the manufacturer. Patients should talk to their doctor or pharmacist if they have heart...

Read more

FDA takes additional action to better understand safety of Essure, inform patients of potential risks

Posted 12 weeks ago in Pharma Industry News

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 implantable forms of sterilization. The FDA issued a new, mandatory clinical study for Essure to determine heightened risks for particular women. The FDA also intends to require changes to product labeling, including a boxed warning and a Patient...

Read more

Monthly News Roundup - February 2016

Posted 12 weeks ago in Pharma Industry News

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 Administration (FDA) has approved Briviact (brivaracetam) as an add-on treatment for partial onset seizures in patients age 16 years and older with epilepsy. Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and...

Read more

FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States

Posted 14 weeks ago in Pharma Industry News

February 16, 2016 -- As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection. “The FDA has critical responsibilities in outbreak situations and has been working rapidly to take important steps to respond to the ...

Read more

Califf, FDA top officials call for sweeping review of agency opioids policies

Posted 16 weeks ago in Pharma Industry News

February 4, 2016 -- In response to the opioid abuse epidemic, today Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. The FDA will: Re-examine the risk-benefit paradigm for opioids and ensure that the age...

Read more
Older articles
Hide