FDA approves low testosterone gel from Abbott | Regulatory roundup

April 30, 2011 By MassDevice staff Leave a Comment

Abbott Laboratories (NYSE:ABT) landed FDA approval for a new testosterone-boosting product.

The company’s AndroGel 1.62% is treatment for male low testosterone levels, also know as hypogonadism, which affects nearly 14 million men in the United States, according to the company.

"Low testosterone is a real concern for many men, and it is important that men exhibiting signs and symptoms talk to their doctor about appropriate testing and treatment," Dr. Natan Bar-Chama of New York’s Mount Sinai Hospital said in prepared remarks.

Abbott said the new colorless, odorless gel is an updated version of its AndroGel 1%, which requires more gel for the same treatment.

The company expects the new AndroGel to be available on the U.S. market before the end of May.

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

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Quest Diagnostics wins CE Mark approval for Epstein Barr and BK Viruse test
Quest Diagnostics Inc. (NYSE:DGX) announced that two new Simplexa-branded molecular test kits developed by its Focus Diagnostics business were granted CE Mark approval. The test kits are designed to enable hospital labs to perform advanced molecular testing for Epstein-Barr (EBV) and BK viruses.
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West Pharmaceutical Services appoints VP, GM of Asia Pacific
West Pharmaceutical Services this week announced it appointed Stewart Campbell as VP and general manager of the Asia Pacific region. Campbell will be responsible for the company’s Asia Pacific business and will lead region teams. “I am honored to serve West in this critical growth market, as it represents significant business opportunities that will ultimately… […]
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Harting Technology Group appears to be engaging in a fine balancing act: The Minden, Germany–based company says it is taking numerous measures to protect its employees, while also providing customer-specific cable assemblies for respiratory equipment and other medical devices needed to fight COVID-19. Several German manufacturers are currently producing the devices on which patients and… […]
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German automotive supplier shifts production to face masks to battle COVID-19
Automotive supplier Wrapping Solutions (Rosengarten, Germany) is partnering with Optima Life Science to produce face masks to help fight the coronavirus pandemic. Wrapping Solutions specializes in producing interior fittings for cars — but has transitioned to sewing 24,000 masks per day at 20 workplaces since March 23. Over the long term, the company plans to… […]
Qosina touts single-use bioprocessing components for coronavirus response
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Amid the global crisis caused by the coronavirus pandemic, hospitals and healthcare facilities are reporting shortages of vital equipment that not only keeps the patients safe, but the staffers, too. One important device for which demand has ramped up is ventilators for patients who need assistance with their breathing due to the respiratory effects of… […]
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