Amphastar Pharmaceuticals, Inc. plans to launch its generic version of Organon’s ganirelix acetate 0.25mg/0.5ml injectable during the current quarter ending 30 June, after receiving the second ever abbreviated new drug application approval for a product referencing the gonadotropin-releasing hormone antagonist.
Amphastar Eyes Sun Pharma Showdown With US Ganirelix Approval
Other ANDA Sponsor Sun Pharma Had Issued Recall Last Year
Amphastar is celebrating what it says is its fourth injectable peptide product approval from the USFDA with its generic version of Organon’s ganirelix acetate, in the process setting up a rivalry with Sun Pharma and commercial partner Ferring Pharmaceuticals.
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