Navigation Links
Merz Pharmaceuticals' Belotero(R) Balance PMA Filing Formally Accepted for Review by the FDA
Date:9/11/2009

GREENSBORO, N.C., Sept. 11 /PRNewswire/ -- Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Merz's premarket approval (PMA) application for Belotero(R) Balance.

Belotero(R) Balance is a hyaluronic acid based monophasic gel dermal filler that utilizes a cohesive polydensified matrix (CPM(TM)) technology. This application seeks FDA approval for injection into mid-to-deep dermis for correction of moderate to severe wrinkles and folds.

"The FDA's acceptance for review of the Belotero(R) Balance PMA begins the application review process and signifies the beginning of Merz Pharmaceutical's firm footprint in the American aesthetics market," said Jack Britts, president and CEO of Merz Pharmaceuticals, LLC.

"Upon approval, Belotero(R) Balance will be an exciting addition to the dermal filler category," said Dr. Rhoda S. Narins, M.D., the lead investigator for the Belotero(R) clinical trials.

About Belotero(R)

First launched in Germany in 2005, Belotero(R) is also approved for aesthetic use in the United Kingdom, Italy, Russia, Austria and Switzerland.

About Merz Pharmaceuticals

Merz Pharmaceuticals, LLC, a wholly owned, U.S. subsidiary of the Merz Group of Companies was established in 1995 and develops and commercializes prescription products for Neurology, Dermatology, Podiatry and the #1 non-prescription product for scars, Mederma.

With a 101 year heritage, Merz (KGaA) is known worldwide for its development of original compounds and formulations for medical professionals and consumers in 90 countries. Globally, Merz is a leader in the development of pharmaceuticals for the treatment of neurological and psychological disorders as well as for aesthetic medicine, including products for the treatment of wrinkles and aging skin, hair loss and acne. Research is concentrated in fields that have a strong need for therapeutic innovation such as Alzheimer's disease, Parkinson's disease, tinnitus, chronic pain conditions, addictions, and neuromuscular disturbances.


'/>"/>
SOURCE Merz Pharmaceuticals, LLC
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Access Pharmaceuticals Signs Agreement to Manufacture Its FDA-Approved MuGard in the United States
2. Amylin Pharmaceuticals and Biocon Limited Enter a Global Development and Commercialization Agreement for a Novel Peptide Hybrid
3. Ritter Pharmaceuticals Hires Dr. Howard Foyt as Executive Vice President, Development & Chief Medical Officer
4. Reportlinker Adds US and European Radiopharmaceuticals Market Report
5. Cumberland Pharmaceuticals Launches Caldolor(R) in the United States for Treatment of Pain and Fever
6. Isis Pharmaceuticals to Present at Morgan Stanleys Global Healthcare Unplugged Conference
7. Rib-X Pharmaceuticals, Inc. Appoints Tom Kassberg Chief Business Officer
8. Jazz Pharmaceuticals to Present at Two Upcoming Investor Conferences
9. Anadys Pharmaceuticals to Present at Two Upcoming Investor Conferences
10. Amira Pharmaceuticals to Present at Thomas Weisel Partners Healthcare Conference
11. Steven Holtzman Joins Satori Pharmaceuticals Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: ... “America On The Brink” is the creation of published author, William Nowers. ... As a WWII veteran, he spent thirty years in the Navy. Following ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... that we intend to develop to enable prevention of a major side effect ... hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA listed ...
(Date:10/12/2017)... ... October 12, 2017 , ... On Saturday, October 21, ... relay – Miles by Moonlight to raise money for the American Heart Association Heart ... , Teams will work together to keep their treadmills moving for 5 hours. ...
(Date:10/12/2017)... Miramar, FL (PRWEB) , ... October 12, 2017 ... ... is presenting the latest in wound care advancements to physician colleagues, skilled nursing ... lecture is titled, "Navigating the Treacherous Waters of Wound Care." , "At many ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... Texas , Oct. 11, 2017  True ... services, has amplified its effort during National Breast ... about hereditary cancer risks. ... of Clinical Oncology calculated that more than 10 ... have inherited mutations in BRCA1 or BRCA2 and have ...
(Date:10/5/2017)... ROSEMONT, Ill. , Oct. 5, 2017 /PRNewswire-USNewswire/ ... American Association of Oral and Maxillofacial Surgeons (AAOMS) ... than opioids – to be used as a ... post-surgical pain. ... relationship, the AAOMS White Paper "Opioid Prescribing: Acute ...
(Date:10/2/2017)...  Eli Lilly and Company (NYSE: LLY ... quarter of 2017 on Tuesday, October 24, 2017. Lilly ... with the investment community and media to further detail ... will begin at 9 a.m. Eastern time. Investors, media ... of the conference call through a link that will ...
Breaking Medicine Technology: