In Brief: Serono Gonal-F
Serono Gonal-F: FDA issues "approvable" letter for injectable follicle stimulating hormone follitropin alpha (r-FSH) for ovulation induction on July 16, the user fee deadline for NDA 20-378, which was filed on Sept. 15, 1993. FDA is requiring further quality control data before final approval. Serono plans to submit the information within the next few weeks...
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