Zdrowie i gospodarka · 13/08/2026

FDA to Hold Public Hearing on Kremers Urban Pharmaceuticals' Proposal to Withdraw Approval of Methylphenidate Tablets

The Food and Drug Administration (FDA) is holding a public hearing to discuss Kremers Urban Pharmaceuticals, Inc.'s proposal to withdraw approval of its abbreviated new drug application (ANDA) for extended-release methylphenidate tablets. The hearing will focus on the factual issues related to the withdrawal of approval for ANDA 091695.

Source: Federal Register — Health and Human ServicesOpen original release →

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