Glenmark Pharmaceuticals Inc., USA
(Glenmark) has
been granted final approval by the United States Food & Drug Administration
(U.S. FDA) for Clobetasol Propionate Spray, 0.05%, the generic version of
Clobex®1 Spray, 0.05%, of Galderma Laboratories, L.P. This product will be
manufactured at Glenmark's (Q,N,C,F)* Baddi
plant in India.
According to IQVIATM sales
data for the 12 month period ending January 2018, the Clobex® Spray, 0.05%
market2 achieved annual sales of approximately USD 30.5 million.
Glenmark's current
portfolio consists of 131 products authorized for distribution in the U.S.
marketplace and 63 ANDA's pending approval with the U.S. FDA. In addition to
these internal filings, Glenmark continues to identify and explore external
development partnerships to supplement and accelerate the growth of its
existing pipeline and portfolio.
http://www.myiris.com/news/sector/glenmark-pharma-gets-usfda-nod-for-clobetasol-spray/20180327101937199
