1. Application Forms and Checklist
i) Application For Biopharmaceutics Classification System (BCS) Biowaiver
ii) Application For A Biowaiver: Additional Strength
iii) Bioequivalence Study Report Submission Checklist
2. New Active Ingredients Listed in the Product Comparator List
|
No |
Active Ingredient |
Comparators |
Manufacturer |
|
1 |
Co-Dergocrine Mesylate |
Hydergine Tablet 1mg Hydergine Tablet 1.5mg Hydergine Tablet 4.5mg |
Novartis Farma S.P.A., Italy
Novartis Pharma AG, Switzerland
Novartis Pharma AG, Switzerland |
|
2 |
Fimasartan Potassium Trihydrate |
Kanarb Film-Coated Tablet 60mg Kanarb Film-Coated Tablet 120mg |
Boryung Pharmaceutical Co Ltd, South Korea |
|
3 |
Ibuprofen Lysine |
Nurofen Express 342mg Caplet Nurofen Express 684mg Caplet |
Reckitt Benckiser Healthcare International, United Kingdom Reckitt Benckiser Healthcare International, United Kingdom |
|
4 |
Piroxicam-B-Cyclodextrin |
Brexin Tablet |
Chiesi Farmaceutici S.P.A., Italy |
3. Additional Comparators Added to the Existing Comparator List
|
No |
Active Ingredient |
Additional Comparators |
Manufacturer |
|
1 |
Fenofibrate |
Lipanthyl Capsule 300mg |
Labs Fournier, France |
|
2 |
Ibuprofen |
Nurofen Express 200mg Liquid Capsules Nurofen Express 400mg Liquid Capsules |
Patheon Softgels B.V., Netherlands
Patheon Softgels B.V., Netherlands |
|
3 |
Pravastatin |
Apo-Pravastatin 20mg Tablet Apo-Pravastatin 40mg Tablet |
Apotex Inc, Canada
Apotex Inc, Canada |
|
4 |
Thioguanine |
Lanvis Tablets 40mg |
Excella GmbH & Co. Kg, Germany |
4. Additional Manufacturing Site added to Existing Comparator List
|
No |
Active Ingredient |
Comparator List |
Product Name |
Additional Manufacturing Site |
|
1 |
Amlodipine |
6th |
Norvasc Tablet 5mg Norvasc Tablet 10mg |
Pfizer Pharmaceuticals LLC, United States |
|
2 |
Atazanavir |
ARV |
Reyataz Capsule 100mg Reyataz Capsule 150mg Reyataz Capsule 200mg |
AstraZeneca Pharmaceuticals LP, United States |
|
3 |
Drospirenone 3mg + Ethinyl Estradiol 30mcg |
FDC |
Yasmin Tablet |
Bayer Weimar GmbH und Co. KG, Germany |
|
4 |
Entecavir |
BE |
Baraclude Tablet 0.5mg |
AstraZeneca Pharmaceuticals LP, United States |
|
5 |
Naltrexone Hydrochloride |
BE |
Revia Tablet 50mg |
Bristol-Myers Squibb Australia Pty Ltd., Australia Teva Canada Limited, Canada |
|
6 |
Paroxetine |
9th |
Seroxat 20mg Tablet |
S.C Europharm S.A, Romania GlaxoSmithKline Pharmaceuticals S.A, Poland |
5. Active pharmaceutical ingredient added to “Biowaivers granted based on unavailability/ inaccessibility of comparator/innovator product (List B)”
iv) Dicyclomine HCl