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.The FDA has granted tentative approval for Caraco Pharmaceutical's abbreviated new drug application for escitalopram oxalate tablets, 5mg, 10mg and 20mg, for the treatment of major depressive disorder.
Subscribe to our email newsletter
This tentative approval is for the generic bioequivalent product to Lexapro, which is offered by Forest Laboratories.
Daniel Movens, CEO of Caraco Pharmaceutical Laboratories, said: “We are extremely pleased to receive this tentative approval. The abbreviated new drug application (ANDA) was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”