Interesting idea, but technically should not be allowed. An ANDA Suitability Petition must cite to a reference listed drug (RLD), which must be a drug approved under the NDA or ANDA process (in the rare cases where a generic is the RLD). Indeed, the regulation on ANDA Suitability Petitions (21 CFR 314.93), in subpart (d), specifically states that the
"[t]he petitioner shall identify a listed drug" in his/her petition.
Thus, legally, FDA has no authority to entertain an ANDA Suitability petition under these circumstances. If FDA has ever allowed this to occur, I am not aware of it.
However, there is a chance FDA would allow you to file an ANDA Suitability Petition to change the approved solid ER drug to a liquid ER. However, the agency may require that you show that the release characteristics of the liquid and the solid are comparable.
You might want to reach out to OGD on the last approach to see what they say before filing a petition and do research to see if they have approved similar oral ER to liquid ER petitions in the past.
Would be happy to help if needed. I have been active in the generic drug space since 1984.
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Michael A. Swit, Esq.
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Original Message:
Sent: 01-03-2013 15:15
From: Vincent Argiro
Subject: ANDA Suitability Petition
Question: An OTC NDA product exists in an extended-release solid dosage form for adults only. A firm is capable of producing an extended-release liquid with the same active. Standard-release liquids of this drug are widely available under an OTC monograph and are allowed for pediatric use. Is an ANDA Suitability Petition a possible pathway to FDA approval to market the extended-release liquid in children? If not, why? Thank you.
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Vincent A.
United States
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