The newly approved generic version of valsartan will be produced by Alkem Laboratories, an Indian company headquartered in Mumbai.
The US Food and Drug Administration (FDA) stated that it had prioritised the review of Alkem’s drug application to provide an additional supply of valsartan medication, as a number of batches were recalled due to the discovery of contamination in sartan products last year.
The European Medicines Agency originally discovered valsartan manufactured by Zhejiang Huahai were contaminated with N-Nitrosodimethylamine in July 2018 – a finding which prompted a global recall.
From this starting point, the investigation widened to include further sartan products and manufacturers, as well as uncovering contamination with N-Nitrosodiethylamine and further nitrosamines.
The scale of the recalls sees the FDA expediting the review of products involved, which extends to losartan medication.
Outgoing FDA Commissioner, Scott Gottlieb said, “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.”
Regarding Alkem’s manufacturing processes, the FDA stated that it had required the company to utilise testing methods that demonstrated its product did not contain any nitrosamine impurities.
In January 2019, the FDA released its conclusions on how the impurities had been formed during the manufacturing process, suggesting that it could result from the reuse of materials, such as solvents.
The agency stated that is currently working on implementing new requirements that will “guard against the development of these impurities in drugs.”