Dear Members,
As per guidance on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules,
If the RLD is less than 17 mm in its largest dimension, the generic product should be:
- No more than 20 percent larger than the RLD in any single dimension (the resulting single dimension of the generic should not exceed 17 mm).
- No more than 40 percent larger than the volume of the RLD.
If the RLD is equal to or greater than 17 mm in its largest dimension, the generic product should be:
- No larger than the RLD in any single dimension.
- No larger than the volume of the RLD.
We have conducted the physical characterization of the RLD. The shape of both RLD & Proposed Test product is same. Whereas thickness is slightly higher than the RLD. Please see the below table for more details
|
Tablet
|
RLD
|
TEST PRODUCT(GENERIC)
|
|
L(mm)
|
W(mm)
|
T(mm)
|
V
|
L(mm)
|
W(mm)
|
T(mm)
|
V
|
|
1
|
19.14
|
10.55
|
6.81
|
1375.12
|
19.06
|
10.56
|
7.00
|
1408.9
|
|
2
|
19.15
|
10.56
|
6.77
|
1369.06
|
19.07
|
10.54
|
6.98
|
1402.96
|
|
3
|
19.16
|
10.57
|
6.80
|
1377.14
|
19.05
|
10.54
|
6.97
|
1399.49
|
|
Avg.
|
19.15
|
10.56
|
6.79
|
1373.7
|
19.06
|
10.546
|
6.983
|
1403.6
|
L= Length, W=Width, T=Thickness, V=Volume
Please note that calculation of volume has carried out based on Physical measurements.
Is it acceptable to file the ANDA with the above trade dress where the volume of Generic product is larger than the RLD?
------------------------------
Thanks & Best regards
Rajib Kumar Baishnab
Manager, Regulatory Affairs
The ACME Laboratories Ltd.
Dhamrai, Dhaka-1350, Bangladesh
Ph: +8801990-407587
Email:
rbaishnab.qo@acmeglobal.com------------------------------