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Claris Lifesciences will resume supply of furosemide injection, used to treat fluid retention, in the US following the receipt of prior approval supplement (PAS) for the injection from US Food & Drug Administration (FDA).
Claris Lifesciences had received the original approval for this abbreviated new drug application (ANDA) in January 2014 and was selling the products in the US in 2014. However, since January 2015, Claris Lifesciences had to stop supply to the US as it was facing supply issues from its raw material supplier.
Following this, the company filed a PAS application to append an additional supplier to the ANDA. "This process was done for redundancy and to ensure a consistent supply of the API for its finished formulation sold in the US. With this approval, alternative vendor has been appended to the ANDA, this will allow the company to recommence its supplies to the US," said Claris in a press release on August 12, 2015.
Furosemide injection had been facing supply issues in the US during the past year on various occasions and has also featured in the US FDA shortage list since June 2012.
