FDA Orange Book
Is there a generic for posfrea?
posfrea contains palonosetron. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for posfrea (palonosetron).
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posfrea products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | Discontinued | None | 0 | None |
| solution, intravenous | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 203050, held by AVYXA HOLDINGS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
posfrea NDC codes
Questions
Is there a generic for posfrea?
No. The Orange Book lists no active FDA-approved generic (ANDA) for posfrea (palonosetron).
What is the generic name for posfrea?
The active ingredient in posfrea is palonosetron, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.