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:2/10/2016)... ... February 09, 2016 , ... A new leadership team for Mid-South Youth ... Joe Wiley made the announcement Monday night, Feb. 8, prior to the evening session ... FHU and the creator of GO! Camp, has been named director. Gayle McDonald, currently ...
(Date:2/10/2016)... ... February 09, 2016 , ... Ross ... Specialists are delighted to welcome a new addition to their growing practice. Beginning ... Specialists as a nurse practitioner performing cosmetic procedures including injectables, fillers ...
(Date:2/10/2016)... , ... February 09, 2016 , ... ... concussion, yet the cause of injury may be one of many possible sources: ... PT Continuing Education Course , Mastering Rehab Solutions for the Complexities ...
(Date:2/9/2016)... , ... February 09, 2016 , ... Steven Douglas Associates ... of South Florida Event, an upscale fundraiser held in South Florida. The Inaugural What’s ... guests alike. This year the event will be held in a new, more causal ...
(Date:2/9/2016)... ... 09, 2016 , ... Interstate Restoration LLC, a full service ... the acquisition of Hawaii DKI. Hawaii DKI is one of the more recognized ... who excel at service and response helps support our goal of becoming the ...
Breaking Medicine News(10 mins):
(Date:2/9/2016)...  Bluestar Silicones will promote its Silbione® Biomedical ... implant applications and announce certification of its clean ... West Conference (Booth #1759), February 9-10, at the ... --> Available in 01 through 70 ... physical properties enabling our customers to optimize their ...
(Date:2/8/2016)... -- Alzheimer Diagnostic Tests - Medical Devices Pipeline ... sector report , "Alzheimer Diagnostic Tests - Medical ... Alzheimer Diagnostic Tests currently in pipeline stage. ... products with comparative analysis of the products at ... players involved in the pipeline product development. It ...
(Date:2/8/2016)... Devices - Medical Devices Pipeline Assessment, 2015 Summary ... Medical Devices Pipeline Assessment, 2015" provides an overview of ... This report is prepared using data sourced from in-house ... industry experts. *Note: Certain sections in the report ... and relevance of data in relation to the equipment ...
Breaking Medicine Technology: