Jubilant Life Sciences today said it has received the US health regulator's approval for Donepezil Hydrochloride Tablets, a central nervous system (CNS) drug, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) for tablets in strengths of 5 mg and 10 mg, Jubilant Life Sciences said in a statement.
According to IMS 2010 data, the total annual market sales for Eisai Medical Research Inc's Aricept in strengths of 5 mg and 10 mg stood at $2.6 billion, it added.
Donepezil Hydrochloride Tablets are indicated for the treatment of dementia of the Alzheimer's type and fall under the Central Nervous System (CNS) therapeutic segment.
Commenting on the approval Jubilant Life Sciences Chairman and Managing Director Shyam S Bhartia said: "This will be our first product from the Indian dosage form facility set up in Roorkee, Uttarakhand, for the US market and paves the way for further approvals from this facility."
The generic tablets would be marketed in the US by the company's subsidiary Jubilant Cadista Pharmaceuticals Inc, it said.
Shares of Jubilant Life Sciences today closed at Rs 161.95 on the BSE, up 2.08% from the previous close.
