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FDA approve valsartan generic after shortages of supply

The FDA has approved a new generic version of blood pressure drug valsartan. The approval comes amid shortages in supply after recalls were made in reaction to the discovery of impurities.The generic version will be produced by Mumbai-based firm Alkem Laboratories Limited.

The F.D.A. prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers,” the agency said in a statement.

MHRA issues recall of irbesartan blood pressure meds over carcinogen contamination concerns

Following a number of recalls issued in the US and Europe in the latter half of 2018 for the blood pressure drug valsartan over fears it had become contaminated with cancer-causing carcinogens, the Medicines and Healthcare products Regulatory Agency (MHRA) has called on pharmacies across the UK to recall blood pressure products containing irbesartan due to similar concerns.

FDA expands list of valsartan recalls

The US Food and Drug Administration (FDA) has expanded a list of products containing valsartan that are to be recalled.

The FDA announced an initial recall of drugs containing valsartan, which is used to treat high blood pressure and heart failure, in July of this year after it was discovered that some drugs could have been contaminated with carcinogenic substances. The drug had previously been recalled in 22 countries.

EMA issues global recall of heart drugs over cancer risk contamination

Several drugs designed for the treatment of high blood pressure and heart conditions have been recalled across Europe over fears they could contain a probable carcinogen and thus pose an increased risk of cancer in users, it has emerged.

FDA approves Allergan hypertension fixed-dose combo, Byvalson

Allergan has announced that the US Food and Drug Administration (FDA) has approved its fixed-dose combination, Byvalson (nebivolol and valsartan), for the treatment of hypertension to lower blood pressure.

Novartis sales below forecast in ‘transformative’ year

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Novartis’ fourth quarter sales have faded slightly as growth in pharmaceuticals is beaten back by generic competition, and the firm continues with its plethora of divestment deals.

Overall sales in Q4 were $14.6 billion, a slight decrease of 2% from the same period last year. Novartis chief executive Joseph Jimenez remains upbeat however, adding: “I’m confident that we are positioned for future success.”

Novartis heart drug sees stellar results

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Novartis’ new heart pill has produced stellar results in helping patients with heart failure live longer, making it the first treatment to do so in decades.

The experimental treatment, known at LCZ696, cut the risk of both cardiovascular death and admissions to hospital by a fifth when compared to the ageing ACE-inhibitor enalapril.

The new clinical trials results were showcased at this year’s European Society of Cardiology in Barcelona over the weekend.

Novartis faces data fraud charges in Japan

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Novartis is facing criminal charges in Japan over the alleged falsifying of data for its once big-selling heart drug Diovan.

The Swiss firm is to be charged by Japanese authorities for failing to oversee the work of its ex-employee Nobuo Shirahashi, Tokyo prosecutors announced this week.

The former Novartis employee is accused of providing false data to researchers whose findings were used to promote Diovan (valsartan).

Ranbaxy’s Diovan copycat approved in US

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Ranbaxy has won approval for its copycat form of Novartis’ blockbuster blood pressure drug Diovan, as the Swiss firm finally braces itself for generic erosion in the US.

Novartis actually lost its patent rights to Diovan (valsartan) in the US more than a year and a half ago, but has avoided generic competition because of multiple production quality control problems at Ranbaxy.

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