Indian Firm Pulls Out Heart Drug From US Amid Cancer Risk Probes

Indian Firm Pulls Out Heart Drug From US Amid Cancer Risk Probes

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Hetero pulls heart drug from US amid cancer risk probes

Hetero pulls heart drug from US amid cancer risk probes

Hetero is one of the world’s largest suppliers of HIV/AIDS drugs. Photo: Pradeep Gaur/Mint Mumbai: A unit of India’s Hetero Drugs is recalling some batches of the blood pressure and heart medicine valsartan in the United States, a notice on the US regulator’s website said, amid a wider probe into cancer risks associated with the […]

FDA Clears First ADHD Bedtime Medication

FDA Clears First ADHD Bedtime Medication

The US Food and Drug Administration (FDA) has approved Jornay PM (Ironshore Pharmaceuticals), a novel formulation of methylphenidate that is taken in the evening instead of first thing in the morning to provide early-morning control of symptoms of attention-deficit/hyperactivity disorder (ADHD). Jornay PM is for children aged 6 years and older. It should be taken […]

Valsartan Recall Expanded by FDA and European Medicines Agency

Valsartan Recall Expanded by FDA and European Medicines Agency

Over the past month, contaminated product has been withdrawn in more than two dozen countries: now, additional suppliers have been targeted. Regulators in the United States and Europe have expanded the list of contaminated valsartan medications to include products from two additional suppliers, covering a wide range of brand-name drugs. The original valsartan recall was […]

Skeptical Cardiologist: Where Are My Generic Meds Made?

Skeptical Cardiologist: Where Are My Generic Meds Made?

FDA recalled several versions of the generic blood pressure medication valsartan which were made in China and contained a carcinogen. Since then I have switched many patients from the bad valsartan to losartan or valsartan from presumably-safe manufacturers. It didn’t really occur to me that this could be just the tip of the iceberg until […]

Red Flags Raised at Maker of Recalled Heart Drug a Year Ago

A Food and Drug Administration inspection in May 2017 found that the company, Zhejiang Huahai Pharmaceutical Co. Ltd., ignored quality testing that showed unnamed drugs didn’t meet U.S. standards, according to an agency report posted online on Thursday. The company didn’t look into the failures, and passing results were recorded instead, according to the report. […]

Valsartan Recall Expanded, FDA Investigating Products from Outside China

Valsartan Recall Expanded, FDA Investigating Products from Outside China

More valsartan products are under recall, according to an announcement from the FDA. Added to the list of products under recall are valsartan-containing products manufactured by Hetero Labs Limited in India, labeled as Camber Pharmaceuticals in the U.S. However, not all Camber valsartan products distributed in the U.S. are being recalled, the agency noted in […]

Language Industry Hires at RWS, memoQ, Today Translations, and Teknotrans

Language Industry Hires at RWS, memoQ, Today Translations, and Teknotrans

Clarice Streets joined RWS Life Sciences as Vice President, Global Quality and Process, in June 2018. She describes her role as the company’s “Quality Ambassador.” “As a member of the executive team of RWS Life Sciences, I am responsible for strategy, direction, development, implementation, and continual improvement of quality systems, programs, and processes. I oversee […]