1
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Sermorelin has a documented medical history.

2
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FDA records describe GEREF products previously approved for particular growth-hormone testing and

3
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pediatric growth-hormone deficiency indications.

4
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The products were later discontinued.

5
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In 2013, FDA determined that their withdrawal from sale was not for reasons of safety or effectiveness.

6
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That determination answers a regulatory question about those historical products.

7
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It does not demonstrate that every modern preparation is approved or clinically equivalent.

8
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Claims about adult recovery, body composition, or healthy aging still need evidence matched to the exact

9
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population and outcome. Historical approval alone cannot supply missing clinical trials for a different

10
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use.