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Valsartan Shortage: Alkem Labs gets USFDA nod to generic Diovan


Valsartan Shortage: Alkem Labs gets USFDA nod to generic Diovan

Valsartan, sold under the trade name Diovan among others, is a medication used to treat high blood pressure, heart failure, and diabetic kidney disease.

New Delhi: In a major relief to patients, the U.S. Food and Drug Administration recently approved a new generic of heart medicine valsartan and said it prioritized the drug’s review to help relieve recent shortage as manufacturers around the world have pulled the treatment from market.

The approval of the generic, Diovan, was granted to Alkem Laboratories Ltd, the FDA said in a statement.

Valsartan, sold under the trade name Diovan among others, is a medication used to treat high blood pressure, heart failure, and diabetic kidney disease. It is a reasonable initial treatment for high blood pressure. Versions are available as the combinations valsartan /hydrochlorothiazide and valsartan /amlodipine.

Valsartan is an angiotensin-receptor blocker (ARB) that may be used to treat a variety of cardiac conditions including hypertension, diabetic nephropathy. According to a 2018 Reuters analysis of national medicines agencies’ records, more than 50 companies around the world have recalled valsartan mono-preparations or combination products manufactured from the tainted valsartan ingredient.

Several drugmakers, including Teva Pharmaceutical Industries Ltd and Mylan NV, have recalled batches of valsartan as the drugs have been found to contain probable carcinogens.

Medical Dialogues had earlier reported that Teva Pharmaceutical Industries Ltd was recalling certain combinations of blood pressure drug valsartan in the United States following the detection of a probable cancer-causing impurity, the latest global recall of the medicine.

The Israeli drugmaker will recall all lots of amlodipine-valsartan and amlodipine-valsartan-hydrochlorothiazide combination tablets due to an impurity in an ingredient made by an India-based unit of Mylan.

Also Read: Teva to recall blood pressure medicines containing Valsartan in US

Over the past year, global health authorities have been cracking down on valsartan and drugs containing the substance as an active ingredient after several batches were found to contain NDEA and a second possible carcinogen, N-nitrosodimethylamine (NDMA).

In October 2018, USFDA halted imports of drug ingredients or medicines containing ingredients produced at a factory belonging to a Chinese bulk manufacturer of valsartan, Zhejiang Huahai Pharmaceuticals.

Alkem Laboratories is a multinational pharmaceutical company headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical generics, formulations and neutraceutricals in India.



Source: with inputs
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