USFDA

Torrent Pharma expanding its recall for Losartan Potassium Tablets

  • Posted on: 1 October 2019
  • By: PharmaTutor News

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis.

FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels

  • Posted on: 1 October 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration  approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones).

It is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s small blood vessels become inflamed, reducing the amount of blood that can flow through them. This can cause serious problems and damage to organs, most notably the lungs and the kidneys. It also can impact the sinuses and skin.

FDA new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

  • Posted on: 28 September 2019
  • By: Shalini.Sharma

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.

FDA continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths

  • Posted on: 25 September 2019
  • By: Shalini.Sharma

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.

FDA alerting patients and health care professionals of NDMA found in samples of ranitidine

  • Posted on: 16 September 2019
  • By: Shalini.Sharma

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.

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

  • Posted on: 30 August 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s 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.

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations

  • Posted on: 22 August 2019
  • By: Shalini.Sharma

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.

EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

  • Posted on: 22 August 2019
  • By: Shalini.Sharma

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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