- Despite posting topline and bottom-line beats with its Q2 2022 financials, Amphastar Pharmaceuticals ( NASDAQ: AMPH ) fell ~14% on Tuesday after the company disclosed the recent FDA rejections of marketing applications for two generic drugs.
- During the earnings call on Monday, Dan Dischner, Amphastar's ( AMPH ) Vice President of Corporate Communications, revealed that the FDA issued a complete response letter rejecting the marketing application for AMP-002, a non-hormonal contraceptive used by women.
- Noting the addressable nature of concerns raised by the FDA, Dischner said that the company would respond to the CRL this quarter and expect a GDUFA action date for the filing in 1Q 2023.
- "While this news is certainly not one we would have liked to receive, we remain confident with AMP-002's future commercial prospects as it remains without any generic," Dischner remarked.
- Additionally, the company expects to file a response in Q4 2022 for the CRL it received in June for AMP-015, a generic for osteoporosis drug teriparatide.
- Citing IQVIA data, Amphastar ( AMPH ) said in April that injectables AMP-002 and AMP-015 targeted drugs with an annual sales opportunity of $950M in 2021.
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Amphastar sheds 14% after announcing FDA rejection of generic drugs