Cosette Pharmaceuticals Acquires Ambien® and Ambien CR® (Zolpidem Tartrate) Tabs from Sanofi US in the US Market
Breckenridge Pharmaceutical, Inc. announced today that it has launched Zolpidem Tartrate Extended-Release Tablets, USP (generic for Ambien® CR), manufactured by Centaur Pharmaceuticals Pvt. Ltd. Breckenridge will market the product in its own label and offer 6.25 mg and 12.5 mg strengths in bottles of 100. According to industry sales data, Ambien CR and its generics had annual sales of $42 million during the twelve months ending May 2021. The U.S. Food and Drug Administration previously granted final approval of this product's Abbreviated New Drug Application.
Centaur Pharms Pvt.’s Generic Zolpidem Tartrate Receives Approval in the US
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.
Merck & Co/MSD has claimed FDA approval for a new use of its insomnia drug Belsomra, treating sleep disruption in people with mild-to-moderate Alzheimer’s disease.
Minerva Neurosciences’ seltorexant helped patients fall asleep more quickly and stay asleep for longer, beating placebo and Sanofi’s insomnia med Ambien in a phase 2b study. The company’s stock leapt as high as 86% Monday morning to $7.85 a share before settling down around the $6.00 mark.
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:
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
A small Cambridge, Massachusetts-based company is hoping its bet on CNS drugs using a well established pharmaceutical approach — allosteric modulators — will cement its place as a biotech powerhouse in the years to come. Cadent Therapeutics — currently a 9-person team — has already found a partner in Novartis $NVS.