Lupin updates on shipment of Mirabegron ER Tablets

Lupin Ltd has announced that the US Court has lifted the Temporary Restraining Order and denied Astellas' request for a preliminary injunction on Mirabegron ER Tablets. Thereafter, shipment of the product has now resumed.

Mirabegron ER Tablets, 25 mg are a generic equivalent of Myrbetriq Extended-Release Tablets, 25 mg of Astellas Pharma Global Development, Inc., and were launched by Lupin in April 2024.

Aurobindo Pharma gets 1 observation from USFDA

The United States Food and Drug Administration (US FDA) inspected Unit-VII, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, situated at Parwada Mandal, Anakapally District, Andhra Pradesh from May 5 to 10, 2024.

The inspection closed with 1 observation. The observation is of procedural in nature and will be responded to within the stipulated time.