Merz Pharmaceuticals' Belotero Balance PMA Filing Formally Accepted for Review by the FDA

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 Balance.

Belotero(R) Balance is a hyaluronic acid based monophasic gel dermal filler
that utilizes a cohesive polydensified matrix (CPM) 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 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 Balance will be an exciting addition to the dermal
filler category," said Dr. Rhoda S. Narins, M.D., the lead investigator for
the Belotero clinical trials.

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

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