You state the 130 mg tab will be divisible by2 or 4. Assume that means they are scored in which case be mindful of FDA Guidance on tablet scoring and the data required to support scoring. You'll want to continue stability on the batches you are using to support the supplement. Since you plan to include a full scale batch you can probably get away with discontinuing pilot scale batch testing. You can try for the same 10 yr shelf life for 130 mg. I haven't worked with ANDAs in along time, but if the standard is to submit data on 3 batches then I would suggest contacting your FDA Project Manager to discuss how to handle submitting less # batches (ex. one pilot and one full scale). You may want to reconsider halting stability testing of pilot batch. Otherwise I your strategy appears sound.
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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 10-Jun-2023 17:16
From: Anonymous Member
Subject: Addition of new tablet strengths
This message was posted by a user wishing to remain anonymous
Hoping to receive feedback on the following scenario and strategy.<o:p></o:p>
<o:p></o:p>
We currently have approval for 65mg tablets. We are planning to file a sANDA to add 130 mg strength. <o:p></o:p>
Product is manufactured through conventional dry blending/compression steps. <o:p></o:p>The additional dosage of 130 mg is based on a homothetic mixture from 65 mg (tablets will be twice bigger) under the same ANDA. The 130 mg tablets, identically to the 65 mg tablets, will be divisible in 2 or 4 equal doses. Manufacturing site, process, batch size and packaging are identical to 65 mg tablets. The current shelf-life (SL) is 10 years for 65 mg.
Plan is to submit a Prior Approval Supplement to include the following:<o:p></o:p>
- 3M real time and accelerated stability data on one batch of 130mg.<o:p></o:p>
- Dissolution profile comparison data comparing the new 130 to the approved 65 mg<o:p></o:p>
- Bioequivalence: To show that dissolution is discriminatory + Biowaiver based on comparative dissolution profile against Reference Listed Drug (130 mg) and existing dosage (2 x 65 mg tablets) on 1 batch only. <o:p></o:p>
<o:p> </o:p>
Questions:<o:p></o:p>
- Does this strategy make sense?<o:p></o:p>
- Do we need to carry on the pilot batches stability, or they can be dropped and replaced by the new batches (process validation/commercial) for the stability? <o:p></o:p>
- Planning to submit 1 pilot scale and 1 commercial scale batch to already have at least 1 PV batch.
- Can we claim the maximum shelf-life (ie. 10 years already registered for the 65 mg dosage).
- Can we request the waiver from FDA to submit only one lot of stability data for PAS?<o:p></o:p>
<o:p></o:p>
Thank you.<o:p></o:p>
<quillbot-extension-portal></quillbot-extension-portal>