AMIDE RECEIVES FINAL APPROVAL FOR MIRTAZAPINE ORALLY DISINTEGRATING TABLETS

Amide Pharmaceutical has received final approval from the FDA for its abbreviated new drug application (ANDA) for mirtazapine orally disintegrating tablets (ODT) in 15-, 30- and 45-mg dosage strengths. The product was developed by Par Pharmaceuticals' wholly owned subsidiary, Kali Laboratories. Mirtazapine ODT is the generic version of Organon's Remeron SolTab and is indicated for the treatment of major depressive disorder. As one of two applicants first to file an ANDA containing a Paragraph IV certification, Amide has been awarded 180 days of shared marketing exclusivity for the 45-mg dosage strength. Organon launched an authorized generic version of the 45-mg strength in October 2004. Annual U.S. sales of mirtazapine ODT tablets are approximately $90 million. Amide said it will begin shipping its mirtazapine ODT products shortly.