Tag: FDA

Natco Pharma’s Vizag FDF unit gets 4 U.S. FDA observations

August 21, 2026 admin

The U.S. Food and Drug Administration (U.S. FDA) has issued a Form 483 with four observations to Natco Pharma after inspecting the generic drugmaker’s finished dosage formulations (FDF) unit in Visakhapatnam. The U.S. FDA had conducted the inspection from August 17-21. Natco Pharma said it believes the observations are procedural in nature and is confident…

Business

Lupin gets U.S FDA nod for Pitolisant tablets

August 17, 2026 admin

Drugmaker Lupin on Monday said it has received the final approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Pitolisant Tablets, 4.45 mg and 17.8 mg. The U.S. FDA has approved the company’s generic as bioequivalent to Harmony Biosciences’ Wakix for the indications in the approved labeling….

Business

US Food Authority Chief Resigns Amid Trump’s Mass Firings: Report

February 19, 2025 admin

Washington, United States: A senior US Food and Drug Administration official who recently oversaw the agency’s banning of a coloring linked to cancer has resigned to protest “indiscriminate” firings by President Donald Trump’s government, reports said Tuesday. Jim Jones, who joined the FDA in 2023, wrote in a letter seen by Bloomberg News that the…

World

Maharashtra Revokes Licence Of McDonald’s Outlet After Action Over Cheese

February 24, 2024 admin

The action was taken against McDonald’s outlet in Maharashtra’s Ahmednagar (Representational) Mumbai: The Maharashtra Food and Drug Administration (FDA) has revoked the licence of a McDonald’s outlet in the state’s Ahmednagar district after taking action against it over cheese, an official said on Saturday. The eatery belonging to the fast food giant had faced FDA…

Nation