Lotus Pharmaceutical submits generic Xenical ANDA with FDA

Dec 11 2012

Lotus Pharmaceutical Company Inc. has confirmed its submission of Abbreviated New Drug Application ("ANDA") for Orlistat capsules, a generic version of Xenical®, to the US Food and Drug Administration (FDA). Lotus has informed Hoffman La Roche on the Paragraph IV certification within 20 days of its submission at the end of September, notifying them of the application and providing documents on non-infringement. So far, Roche has not filed a patent lawsuit within 45 days in accordance with current regulations.

Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet.