FDA Approves Generic for Diovan

March 13, 2019

Ongoing valsartan shortages due to recalls prompt FDA prioritization.

As a result of the valsartan shortage stemming from multiple recalls, the FDA has issued a clearance for a generic version of Diovan to Alkem Laboratories. Many lots of valsartan and related drugs have been recalled due to contamination with a chemical that is a possible carcinogen.

The FDA reportedly prioritized the review to help relieve the recent shortage of the critical medicine. One of the FDA’s abilities is to expedite and prioritize reviews of new or generic drugs that would hopefully resolve severe shortages of critical medications. 

Valsartan is indicated for the treatment of hypertension, heart failure, and the reduction of cardiovascular mortality in clinically stable patients who have left ventricular failure or left ventricular dysfunction following myocardial infarction. 

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“We’ll continue to work with manufacturers so that more medicines like valsartan, that belong to a class of drugs called angiotensin II receptor blockers, can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage,” says Scott Gottlieb, MD, commissioner of the FDA.  

Some lots of valsartan, losartan, and irbesartan were found to contain a type of nitrosamine called N-nitrosodimethylamine (NDMA). NDMA can form during manufacturing if the chemical process to make the drug is not carefully controlled and monitored, the F.D.A. said.

The generic version of Diovan has not yet been given a commercial release date by Alkem Laboratories Ltd, based in India.

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