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.”