Asta Medica Cetrotide Approved For Single- And Multiple-Dose Regimens
Executive Summary
Asta Medica's Cetrotide (cetrorelix) controlled ovarian stimulation injection received FDA approval for a 3 mg single-dose regimen and a .25 mg multiple-dose regimen on Aug. 11.
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Serono Cetrotide
Gonadotropin releasing hormone will be marketed, distributed and sold exclusively by Serono under a deal reached with Asta Medica. The two companies were scheduled to co-promote Cetrotide (cetrorelix) worldwide except for Japan. The NDA, approved Aug. 11, will now be transferred to Serono (1"The Pink Sheet" Aug. 21, p. 10)