USFDA

- Read more about FDA new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight
U.S. Food and Drug Administration released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.
Patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation. These tools provide patients with a wealth of easily-accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes.
- Read more about FDA continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths
Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can address this crisis. As we observe Prescription Opioid and Heroin Epidemic Awareness Week, a time when we acknowledge the devastating toll the opioid crisis has inflicted on our country, we felt it was essential to clarify important information about naloxone, an emergency opioid overdose reversal treatment. Naloxone is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths.
- Read more about FDA alerting patients and health care professionals of NDMA found in samples of ranitidine
The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
- Read more about Lupin receives U.S. FDA approval for Ethacrynic Acid Tablets USP
Pharma major Lupin Limited (Lupin) announced that it has received approval for its Ethacrynic Acid Tablets USP, 25 mg, from the United States Food and Drug Administration (U.S. FDA).
The U.S. Food and Drug Administration approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa carbidopa in adult patients with Parkinsons disease (PD) experiencing off episodes. An off episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremor and difficulty walking.

According to the National Institutes of Health, PD is the second-most common neurodegenerative disorder in the U.S. after Alzheimer’s disease. An estimated 50,000 Americans are diagnosed with PD each year, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, although it can occur earlier. It happens when cells in the brain, which produce a chemical called dopamine, become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movements – such as eating, writing, and shaving. Early symptoms of the disease are subtle and typically worsen gradually; however, the disease progresses more quickly in some people than in others.

The effectiveness of Nourianz in treating "off" episodes in patients with PD who are already being treated with levodopa/carbidopa was shown in four 12-week placebo-controlled clinical studies that included a total of 1,143 participants. In all four studies, patients treated with Nourianz experienced a statistically significant decrease from baseline in daily “off” time compared to patients receiving a placebo.

The most common adverse reactions observed in patients taking Nourianz were involuntary muscle movement (dyskinesia), dizziness, constipation, nausea, hallucination and sleeplessness (insomnia). Patients should be monitored for development of dyskinesia or exacerbation of existing dyskinesia. If hallucinations, psychotic behavior, or impulsive/compulsive behavior occurs, a dosage reduction or stoppage of Nourianz should be considered. Use of Nourianz during pregnancy is not recommended. Women of childbearing potential should be advised to use contraception during treatment.

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- Read more about Strides acquires USFDA approved manufacturing facility in the US
Strides Pharma Science Limited (Strides) announced that its step down subsidiary Strides Pharma Inc.(SPI) has acquired a USFDA(FDA) approved manufacturing facility in Florida, US from Micelle BioPharma, Inc.
- Read more about FDA warns company for putting consumers at risk with drug manufacturing data integrity violations
U.S. Food and Drug Administration posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) violations, including data integrity issues.
- Read more about EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines.
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- Read more about FDA warns consumers about the dangerous and potentially life threating side effects of Miracle Mineral Solution
The U.S. Food and Drug Administration is warning consumers not to purchase or drink a product sold online as a medical treatment due to a recent rise in reported health issues. Since 2010, the FDA has warned External Link Disclaimer consumers about the dangers of Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide (CD) Protocol, Water Purification Solution (WPS) and other similar products. Miracle Mineral Solution has not been approved by the FDA for any use, but these products continue to be promoted on social media as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. However, the solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects.
- Read more about FDA approves first therapy for rare joint tumor
U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.