A few years ago India’s Alkem Laboratories was in the hot seat with the FDA, having had several plants cited by inspectors. Today it is in the driver’s seat after the agency approved its new generic Diovan to help relieve shortages flowing from massive recalls of tainted versions of valsartan.
The FDA announced Tuesday that it had approved the new generic only after ensuring that Alkem’s products are free of NDMA and NDEA, the cancer-causing impurities that have developed during manufacturing of many drugmakers’ offerings of the ubiquitous high blood pressure drug.
It said that its review of Alkem manufacturing processes determined that there is no known risk for the formation of other nitrosamine impurities. The FDA this month said that a third impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), had been discovered in the API of Aurobindo losartan, leading to the recall of nearly 90 lots of that drug.
“We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines,” outgoing FDA Commissioner Scott Gottlieb, M.D., said in a statement. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”
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The FDA has been aggressively trying to cleanse the drug supply of the impurities after they were first discovered in valsartan last summer, and since in losartan and irbesartan. That, however, has also led to shortages. The FDA has said it expects other sartan drugs to come up short as well.
The agency said it can now expedite review of drugs that can help relieve the shortages and is working with manufacturers to see if they can make additional supplies.
The FDA determined the impurities are created in the manufacturing process and may result from the reuse of materials, such as solvents. It has developed new tests to check for the contaminants.
Alkem, which has 14 manufacturing sites in India, had its manufacturing practices come under FDA review several years ago after the agency was alerted to problems by U.K. regulators. The U.K. claimed the drugmaker had used fake data in clinical trials of an unspecified antibiotic and brain disorder drug. A series of FDA inspections resulted in a series of Form 483s, including for an Alkem plant in Daman that included more than a dozen observations. Alkem said at the time that it was addressing the issues.
