What does “Sermorelin orphan designation” mean?
Orphan drug designation is a regulatory status that the FDA grants to a medicine intended to treat a rare disease or condition. When a drug is granted orphan designation, it can become eligible for incentives such as market-exclusivity protections if the drug is later approved for the designated indication.
Your wording suggests you’re looking for the FDA’s orphan-designation event date for sermorelin—specifically “February 13, 1990.”
Is February 13, 1990 the FDA orphan designation date for sermorelin?
I can’t confirm the exact FDA orphan-designation date from the information provided in your question alone. To verify it precisely, you would need the FDA orphan-drug designation record (often available through the FDA orphan products database) for sermorelin and then match the listed designation date to February 13, 1990.
Where can you verify the orphan designation record and date?
The most reliable place to check is the FDA’s orphan product/designation database, searching for:
- Drug name: sermorelin
- Event type: orphan designation
- Then read the “designation date” field to see whether it shows February 13, 1990.
Why would someone search for sermorelin’s orphan designation date?
Common reasons include:
- Determining what indication the orphan designation covered at the time.
- Estimating potential exclusivity timelines tied to designation/approval (exclusivity rules depend on approval status and indication).
- Researching regulatory history for a specific product or labeling claim.
What I need to answer with precision
If you paste any of the following, I can tell you what happened on that date and how it fits the regulatory record:
- the FDA link/record you found, or
- the orphan designation entry text, or
- the exact indication listed alongside sermorelin in that February 13, 1990 entry.
Sources: none (the query didn’t include a document or link to cite).