Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Taro Pharmaceutical Industries has received tentative approval from the FDA for its abbreviated new drug application for Lamotrigine tablets 25mg, 100mg, 150mg, and 200mg.
Subscribe to our email newsletter
Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline’s Lamictal tablets.
The tentative ANDA approval for Taro’s Lamotrigine tablets is an FDA determination that Taro’s ANDA submission for this product satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions or any new information that may come to the FDA’s attention.