Glenmark Generics today said it has received ANDA (abbreviated new drug application) approval from the United States Food and Drug Administration for Ciclopirox Olamine cream, used in the treatment of dermatological infections.
The company will start marketing and distribution of the product in the US market, a press release issued here said.
Glenmark Generics (GGL) is a subsidiary of Glenmark Pharmaceuticals Ltd.
Ciclopirox Olamine cream is the generic equivalent of Loprox cream marketed by Medicis.
The product generated USD 8 million sales in the 12-month period ended September 2009.
The broad-spectrum anti-fungal is indicated for the topical treatment of dermatological infections.
Glenmark has 46 ANDAs pending approval with the US FDA, the release said, adding "GGL continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio."
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