US Launch Of Sensipar Generics May Await Patent Case Even After FDA Approval
Aurobindo remains embroiled in litigation with Amgen on a Sensipar formulation patent, while Cipla settled ahead of bench trial. Generic firms won approval of cinacalcet generics after two federal courts denied Amgen's emergency request for an injunction in dispute with FDA over pediatric exclusivity.
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However, FDA must explain why denial of Sensipar's pediatric exclusivity was consistent with exclusivity award for J&J's Ortho Tri-Cyclen, US judge says. In swipe at plaintiff Amgen, court says pediatric study reports themselves guide exclusivity determinations, not the amount of effort a sponsor puts into those studies.
As a reviewer, team leader and deputy director in the Division of Metabolism and Endocrinology Products, Colman spearheaded the agency’s policy development on weight-management products.
US FDA’s expedited pathway remains alive and well in oncology, but ‘dangling’ indications may be subject to more regular public scrutiny going forward; negative votes for two of six indications reflected the influence of Oncology Center of Excellence director Richard Pazdur.