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Home » FDA approves low testosterone gel from Abbott | Regulatory roundup

FDA approves low testosterone gel from Abbott | Regulatory roundup

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Clearances roundup

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.

  • STAAR Surgical wins CE Mark approval for nanoFLEX Collamer IOL
    STAAR Surgical Company (NSDQ:STAA) announced CE Mark approval for its nanoFLEX Collamer Single Piece IOL which can be injected through a 2.2 mm incision with the nanoPOINT Injector System. The nanoFLEX IOL incorporates the company’s aspheric optic design, which is optimized for the naturally curved anatomy of the eye.
    Read more

  • IDEV wins Australian approval for Supera Veritas
    IDEV Technologies Inc. announced the firm has received approval from the Therapeutic Goods Administration (TGA), Australia’s regulatory agency for medical drugs and devices, for the SUPERA VERITAS stent system for use in biliary and peripheral procedures.
    Read more

  • Maquet Cardiovascular wins 510(k) clearance for Cardiohelp
    Maquet Cardiovascular announced that the FDA granted the company 510(k) clearance to market its CARDIOHELP System as a cardiac and/or respiratory assist device for up to six hours. The CARDIOHELP System is a portable heart-lung support system providing extracorporeal life support (ECLS) to replace or support a patient’s circulation and respiration. The product is expected to be commercially available in the U.S. later this year.
    Read more

  • 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.
    Read more

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