Trials & Filings

EMD Serono Gets Injector Pen Approved

FDA clears pre-filled pen for fertility

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

EMD Serono, Inc., a subsidiary of Merck KGaA, has received FDA approval for the Gonal-f RFF Redi-ject (follitropin alfa injection), a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF. Gonal-f RFF Redi-ject is indicated for induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure, development of multiple follicles in ovulatory women as...

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