Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug ...

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ...

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday told the U.S. District Court for the District of ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

Shortly after Sun Pharmaceuticals Industries filed its abbreviated new drug application (ANDA), Allergan asserted that Sun infringed, among others, claim 40 of the ’356 patent. Sun argued that claim ...

The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

MORRISVILLE, N.C., Sept. 16, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: LQDA) (Liquidia), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases, announced ...

Hearing loss affects millions of people, but hearing aids have been expensive and sales have been dominated by a few ...

An abbreviated summary of the most clinically ... 2006 Voluntarily at any time a Includes new drug applications, biological license applications, and efficacy supplements.

It allowed for the creation of abbreviated new drug applications or ANDAs, which don’t require pre-clinical and clinical data of safety and efficacy, but instead merely proof of bioequivalence ...