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30.04.15 13:59

First drug approval for injection-lipolysis in USA

Under the trademark Kybella (TM) the company Kythera has received the FDA approval for double chin....more

Hier die Meinung des NETZWERK-Lipolyse:First approval of a medicament for the treatment of double chin. Congratulation from the NETWORK-Lipolysis, although we still have some critical objections against the single use of deoxycholate.
Erste Medikamentenzulassung für Doppelkinn in USA. Heute ist die Bestätigung der FDA eingetroffen. Das Netzwerk gratuliert, obwohl wir einige kritische Anmerkungen zum Thema "reine Desoxycholsäure" haben.

Hier die Verlautbarung der ISDS: Very Exciting News Today! FDA Approval of KYBELLA(TM), Also Known as ATX-101 - First and Only Submental Contouring Injectable Drug!

  Here's a Press Release from KYTHERA:
  Dear Colleagues,
We’re thrilled to inform you that today the FDA approved KYBELLA™ “for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.” KYBELLA™ is the first and only FDA-approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition.
  The approval of KYBELLA™ is not only a huge milestone for us at KYTHERA, but also for your aesthetic patients who may be looking for a nonsurgical treatment to reduce their submental fullness. As you may know, submental fullness can impact a broad range of adults including both women and men and can be caused by aging, genetics and weight gain. It can detract from an otherwise balanced and harmonious facial appearance – leading to an older and heavier look. In fact, according to a 2014 survey by the American Society for Dermatologic Surgery (ASDS), 68% of consumers are bothered by submental fullness.
  KYTHERA is proud to now be able to offer you a treatment option that allows you to further expand your aesthetic injectable portfolio and offerings to your patients. In the coming weeks you will receive information about training and product availability of KYBELLA™. For more information on today’s announcement, you can access the KYTHERA press release - http://bit.ly/1zrAzMT - distributed today, and visit the new KYBELLA™ website at mykybella.com.  
During clinical trials, the most commonly reported adverse reactions that occurred in at least 20% of KYBELLA™ patients were associated with the injection site and included edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration. For full Prescribing Information, click here - http://bit.ly/1OGoOsA
  If you should receive any media inquiries, please contact our PR Agency (media@kythera.com) who can help you manage these requests.
  Regards,
  Keith Leonard
Chief Executive Officer
KYTHERA Biopharmaceuticals

  Elisabeth Sandoval
Chief Commercial Officer
KYTHERA Biopharmaceuticals

  Frederick Beddingfield
Chief Medical Officer
KYTHERA Biopharmaceuticals

  Ryan Irvine
VP Medical Affairs
KYTHERA Biopharmaceuticals


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