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Claris Lifesciences Ltd on Tuesday said it has addressed the issues raised by the US Food and Drug Administration (USFDA) about the company’s products, enabling it to re-enter the American market.
The company said in a statement here it has formally received a letter from the USFDA stating that the latter has completed its evaluation of the firm's corrective actions in response to its "warning letter'' of 2010.
Based on its evaluation, the USFDA had informed Claris on August 14 that the violations have been addressed.
Claris has received seven abbreviated new drug applications (ANDAs) approvals across four products before the warning letter was issued.
The company has, so far, filed for 32 ANDAs cross 21 products having an estimated market size of $one billion in the US.
The USFDA approval will allow the company to manufacture and sell its products into the US and receive ANDA approvals. It will also enable Claris to file more products in the US market.
"We look forward to re-entering the United States,'' said Arjun Handa, MD & CEO, Claris Lifesciences Ltd.
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