Updates on Bioequivalence (BE) Webpage (August 2018): Immediate Release Solid Oral Dosage Form

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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
MAL19870102A

Hydergine Tablet 1.5mg
MAL19870106A

Hydergine Tablet 4.5mg
MAL19870111A

Novartis Farma S.P.A., Italy

 

Novartis Pharma AG, Switzerland

 

Novartis Pharma AG, Switzerland

2

Fimasartan Potassium Trihydrate

Kanarb Film-Coated Tablet 60mg
MAL8026063ARZ

Kanarb Film-Coated Tablet 120mg
MAL18026065ARZ

Boryung Pharmaceutical Co Ltd, South Korea

3

Ibuprofen Lysine

Nurofen Express 342mg Caplet
MAL13085058AZ

Nurofen Express 684mg Caplet
MAL13085061AZ

Reckitt Benckiser Healthcare International, United Kingdom

Reckitt Benckiser Healthcare International, United Kingdom

4

Piroxicam-B-Cyclodextrin

Brexin Tablet
MAL19992991AZ

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
(MAL19930138A)

Labs Fournier, France

2

Ibuprofen

Nurofen Express 200mg Liquid Capsules
(MAL18016015ACRZ)

Nurofen Express 400mg Liquid Capsules
(MAL18016016ACRZ)

Patheon Softgels B.V., Netherlands

 

Patheon Softgels B.V., Netherlands

3

Pravastatin

Apo-Pravastatin 20mg Tablet
(MAL20040229ARZ)

Apo-Pravastatin 40mg Tablet
(MAL06030825AZ)

Apotex Inc, Canada

 

Apotex Inc, Canada

4

Thioguanine

Lanvis Tablets 40mg
(MAL13065045ACZ)

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