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:2/8/2016)... ... 08, 2016 , ... A man who has struggled to quit smoking, a man who has ... determined to find solutions to his problems – and he did. Now Nabat, a serial ... to introduce his breakthrough inventions to the world and better people's lives. His own experience ...
(Date:2/8/2016)... Hilton Head Island, SC (PRWEB) , ... February 08, 2016 , ... ... Head and surrounding areas with a vital new community enrichment program, has teamed up ... to local women and children suffering from intimate abuse. To support all those victimized ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... today that nominations will be accepted February 8, 2016 through May 8, ... Awards include the Information Security Executive® of the Year, which recognizes executives ...
(Date:2/8/2016)... ... February 08, 2016 , ... Discover the Rocky Mountain region’s longest ... and 700 companies. Attendees also get to see the most incredible gardens and ... Home Show , at the Colorado Convention Center - 700 14th St. Denver CO, ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... speaking on how healthcare companies can use newly released government data on populations ... a population and intervene and capture the value they create to succeed in ...
Breaking Medicine News(10 mins):
(Date:2/9/2016)... 2016 The life of Dr. Jan Vilcek ... anything but ordinary.  Twists of fate, combined with sheer grit, ... the constraints of communist Czechoslovakia to New York ... on to make history by playing a key role in ... the world, Remicade.  Dr. Vilcek brings readers along his improbable ...
(Date:2/9/2016)... 2016 The new report "Global Anti-Bacterial Drugs Market Assessment ... Consulting group reveals that the North America ... 38.9% in 2014 that translated into revenues worth US$ 16,907.3 million. ... , Asia-Pacific , Latin America ... . The global anti-bacterial market is inclined towards ...
(Date:2/8/2016)... , Feb.8, 2016 Alzheimer Diagnostic ... Summary Medical Devices sector report , ... 2015" provides an overview of Alzheimer Diagnostic Tests ... comprehensive information on the pipeline products with comparative ... development. The report reviews major players involved in ...
Breaking Medicine Technology: