Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for its generic Imiquimod cream used for treating skin disorders.
Glenmark Generics Inc, the company’s subsidiary, has received final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for its Imiquimod cream 5 per cent and has commenced shipping it, Glenmark Pharmaceuticals said in a statement.
The cream is a generic version of Medicis Pharmaceutical Corporation’s Aldara, it added.
“According to IMS Health sales data for the 12-month period ending December 2011, Imiquimod cream garnered annual sales of approximately $244 million,” the company said.
The company has 77 products authorised for distribution in the US market and 40 ANDAs pending approval with USFDA, it added.
The scrips of Glenmark Pharmaceuticals were today trading at Rs 292 per share in afternoon trade on the BSE, down one per cent from its previous close.