Merz Pharmaceuticals' Belotero(R) Balance PMA Filing Formally Accepted For Review By The FDA

Main Category: Seniors / Aging
Also Included In: Regulatory Affairs / Drug Approvals;  Dermatology;  Pharma Industry / Biotech Industry
Article Date: 16 Sep 2009 - 2:00 PDT


Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, 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

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