Short summery of US FDA new drug application

1. New Drug Application
The New Drug Application (NDA) is the vehicle in the United
States through which drug sponsors formally propose that
the Food and Drug Administration (FDA) approve a new
pharmaceutical for sale and marketing.

2. 3 types of New Drug Application
“Full” New Drug Application – 505(b)(1)
– Includes results of human clinical trials sufficient to
– prove safety and efficacy
505(b)(2) Application
– Relies, at least in part, on published information or
– FDA’s past finding of safety and efficacy
– Examples: new dosage form, strength, route of
– administration, dosing regimen, indication
Abbreviated New Drug Application – 505(j)
– Same active ingredient,
– dosage form, strength, route
– Need prove only bioequivalence

3. The 505(b)(2) application is one of three established types of
new drug application (NDA), and it is a pathway to approval that
can potentially save pharmaceutical sponsors both time and
money.
505(b)(2) Application (1/2)

4. Today, 505(b)(2) can provide relatively fast-track approval for a wide range
of products, especially for those that represent a limited change from a
previously approved drug. Ideal candidates include:
• New indications
• Changes in dosage form, strength, formulation, dosing regimen or
route of administration
• New combination products
• New active ingredients
• Pro-drug of an existing drug
505(b)(2) Application (2/2)

5. • That are covered under Section 505(j)
• For which the only difference is lower extent of
absorption than reference drug
• For which the only difference is an unintended lower
rate of absorption than reference drug
The 505(b)(2) applications are not
appropriate for products

6. For further info:
Nazmul Hasan Mahmud
Assistant Manager, International Business
Eskayef Bangladesh Limited
158/E Kemal Ataturk Avenue, Dhaka – 1213
Bangladesh
Email: nhmshuvo@gmail.com
LinkedIn: http://bd.linkedin.com/in/nhmshuvo