Glenmark Generics gets US FDA nod for Ciclopirox Olamine
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.
- Glenmark Pharma net dips 31% - Glenmark Pharma Q2 net dips 31% to Rs 81 cr - Glenmark Generics aims to raise Rs 570 cr through IPO - Glenmark Generics files IPO prospectus with Sebi - Glenmark raises Rs 413 cr in QIP - Glenmark plans to raise Rs 300-350 cr through QIP
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."