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:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016  In a startling report released today, ... their residents by lacking a comprehensive, proven plan to eliminate prescription ... definitive ranking of how states are tackling the worst drug crisis ... four states – Kentucky , New ... Vermont . Of the 28 failing states, three – ...
(Date:6/23/2016)... Research and Markets has announced the ... 2016 - Forecast to 2022" report to their offering. ... up to date financial data derived from varied research sources ... with potential impact on the market during the next five ... comprises of sub markets, regional and country level analysis. The ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... offering. The current unmet ... for MedImmune to enter. The US ageing population creates a ... considerable growth for effective anti-influenza medications. The introduction of a ... development is still in its infancy. Key ...
Breaking Medicine Technology: