FDA slaps CRL on Amneal's IPX203

5 July 2023

Shares of Amneal Pharmaceuticals (NYSE: AMRX) fell 13.1% to $2.70 in choppy post-market trading, after the US drugmaker revealed that the US drugmaker revealed that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the New Drug Application (NDA) for IPX203 in the treatment of Parkinson’s disease.

The letter indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa (LD), based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa (CD), and FDA has requested additional information. The letter did not identify any issues with respect to the efficacy or manufacturing of IPX203. Amneal will work closely with the FDA to address its comments and plans to meet with the agency to align on the best path forward.

The FDA’s decision is a potential hurdle to the company, which has been looking to grow its portfolio of branded drugs, expecting over $500 million in revenues from its specialty business by 2027.

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