Business · 16/09/2019Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of Impax Laboratories' Ursodiol Capsules 300mg ANDA

Summary

The FDA is withdrawing the approval of Impax Laboratories' abbreviated new drug application for Ursodiol Capsules USP, 300 milligrams, after Impax requested the withdrawal and waived its right to a hearing.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

Add your company to Business Communicator

We monitor business sources and connect attention with companies, profiles and services available in Business Communicator.

Create a free company profile Explore businesses on Business Maps →

Create a free company profile →

Explore insights

Business insights →

Healthcare Business News Global Markets News Trade Regulation News Business Technology News Fintech for Business: Payments & Banking News Supply Chain News

Related business signals

Business · 10/5/2026

CDC Requests Public Comment on Respiratory Protective Devices Data Collection

The Centers for Disease Control and Prevention (CDC) is seeking public input on a proposed data collection project related to Respiratory Protective Devices, as required by the Paperwork Reduction Act of 1995, to inform the approval certification activities under 42 CFR part 84.

Read summary →

Business · 9/17/2026

CMS Approves DNV Healthcare USA Inc. for Continued Hospital Accreditation Program Approval

The Centers for Medicare and Medicaid Services (CMS) has approved DNV Healthcare USA Inc. (DNV) for continued recognition as a national accrediting organization for hospitals participating in Medicare and Medicaid programs.

Read summary →

Business · 9/16/2026

Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pathogen-Agnostic Sequencing

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Microbiology Devices Panel to discuss pathogen-agnostic sequencing for emergency preparedness and response efforts.

Read summary →

Business · 9/16/2026

Food and Drug Administration Announces Proposed Collection of Information for Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Read summary →

Business · 9/16/2026

Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists

The Centers for Disease Control and Prevention (CDC) issued an Order under Sections 362 and 365 of the Public Health Service Act, continuing the suspension of introducing certain persons from countries with a quarantinable communicable disease outbreak.

Read summary →

Business · 9/16/2026

Agency Information Collection Request; 30-Day Public Comment Request

The Office of the Secretary (OS), Department of Health and Human Services, submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval, with a 30-day public comment period.

Read summary →