Hetero`s Generic Eszopiclone Receives Approval in the U.S.
Enforcement Report - Week of July 13, 2022
Taiwan's Food and Drug Administration (FDA) on Tuesday (April 29) banned doctors from prescribing medicine containing any of four ingredients to people who have experienced an episode of sleepwalking or other movements while in a partially conscious state.
If you have trouble sleeping, you're not alone. According to SleepHealth.org, 70% of American adults say they get insufficient sleep at least one night per month, and 11% struggle to get sufficient sleep on a nightly basis.1 As noted by this organization:
Breckenridge Pharm`s Generic Eszopiclone Receives Approval in US
The U.S. Food and Drug Administration today announced the agency is requiring a new boxed warning – the agency's most prominent warning – on certain prescription insomnia drugs to better ensure patients and their health care professionals have the information they need when considering use of these medicines. The boxed warning follows several reports of rare, but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines. These complex sleep behaviors may include sleepwalking, sleep driving and engaging in other activities while not fully awake, such as unsafely using a stove. The new warnings will be required for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist).
The US Food and Drug Administration (FDA) on Tuesday announced the addition of a boxed warning to certain prescription insomnia medicines because of various behaviors, including sleepwalking and sleep driving, that have led to injuries and deaths
Aurobindo Pharma Ltd Generic Eszopiclone Approved In US
A new indication for Sunovion's epilepsy drug Aptiom isn't expected to lead to significant changes to the company's marketing strategy for the drug, a company executive said.