GSK Paxil CR PMDD approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline's selective serotonin reuptake inhibitor Paxil CR (paroxetine) clears FDA Aug. 28 for treatment of premenstrual dysphoric disorder, becoming the first controlled release antidepressant approved for PMDD. The other two approved PMDD therapies, Pfizer's Zoloft (sertraline) and Lilly's Sarafem (fluoxetine), are immediate release SSRI products. Paxil CR may have a dosing advantage over Zoloft, which can require titration when used for PMDD (1Pharmaceutical Approvals Monthly July 1, 2003, p. 11). The CR approval comes soon after the introduction of generic competition to immediate release Paxil; FDA cleared Apotex subsidiary TorPharm's generic version of IR Paxil July 30, but at least three other firms will share exclusivity. Synthon's mesylate-based formulation of paroxetine cleared FDA July 3 as a 505(b)2 NDA and will launch in the fourth quarter...