Claris Lifesciences on Wednesday said it has received Prior Approval Supplement (PAS) for Furosemide injection in the USA.
The company had received the original approval for this ANDA in January 2014 and has been selling the product in the US since. However, since January 2015, it has been facing issues from raw material suppliers and was unable to supply its product to the US, according to a press release here.
The company had filed a PAS application to append an additional supplier to the ANDA to ensure consistent supply of the API for its finished formulation sold in the US. With this approval, an alterative vendor has been appended to the ANDA. This will allow the company to recommence its supplies to the US.
The product had been facing supply issues in the US in the past year and also featured in the US FDA shortage list since June 2012.
Claris is among the few injectables companies in India to have its own front end in the US, where it markets its products through its wholly- owned subsidiary Claris Lifesciences Inc.