This document discusses 505(b)(2) applications, which are a type of new drug application that relies in part on investigations not conducted by the applicant. It provides examples of 4 drugs - Bendeka, Zuplenz, Avycaz, and Narcan - that received FDA approval through 505(b)(2) applications. For each drug, it notes the active ingredient, when the 505(b)(2) was approved, the old and new dosage forms, and intended uses. The document concludes with two references on 505(b)(2) applications.

1. Sinhgad Technical Education Society
Smt. Kashibai Navale College of Pharmacy
505(b)(2) SUBMISSIONS
Ashish Dilip Sutar
FY M-Pharm (Pharmaceutics)

2. A 505(b)(2) application is a new drug application (NDA) described in
section 505 of the Act. Section 505 of the Act describes three types of new
drug applications:
(1)An application that contains full reports of investigations of safety
and effectiveness (section 505(b)(1));
(2)An application that contains full reports of investigations of safety and
effectiveness but where at least some of the information required for
approval comes from studies not conducted by or for the applicant
and for which the applicant has not obtained a right of reference
(section 505(b)(2));
(3)An application that contains information to show that the proposed
product is identical in active ingredient, dosage form, strength, route of
administration, labelling, quality, performance characteristics, and
intended use, among other things, to a previously approved product
(section 505(j)).
INTRODUCTION

3. • API- Bendamustine hydrochloride
• The 505(b)(2) for Eagle Pharma’s Bendeka was approved in
December 2015
• Old form and name- Treanda
Treanda is a powder that requires reconstitution.
(treatment of patients with chronic lymphocytic leukemia (CLL))
• New form and name- Bendeka
Bendeka presented a modified dosage form; comprised of a ready-
to-dilute solution, providing for multiple doses and less infusion
time.
Bendeka™ (bendamustine hydrochloride)

4. • API- Ondansetron
• The 505(b)(2) for Monosol Rx (the developers of PharmFilm
technology) and Strativa (a division of Par) as Zuplenz was
approved in December 2010
• Old form and name- Zofran
Zofran oral dosage form.
(Ondansetron prevents post-operative, chemotherapy and radiation-
induced nausea and vomiting)
• New form and name- Zuplenz
Zuplenz was approved based on demonstration of bioequivalence to
the oral disintegrating tablet.
Zuplenz® (ondansetron)

5. • API- Ceftazidime-avibactam
• The 505(b)(2) for Fierce Pharma’s Avycaz was approved in
December 2015
• Avcyaz is a fixed combination antibacterial indicated for the
treatment of patients 18 years or older with complicated intra-
abdominal infections, used in combination with metronidazole
and complicated urinary tract infections.
• Notably, the avibactam component was a new chemical entity,
while the ceftazidime is a previously approved third-generation
cephalosporin.
Avycaz® (ceftazidime-avibactam)

6. • API- Naloxone hydrochloride
• The 505(b)(2) for Narcan was submitted by Adapt Pharma on
July 20, 2015 and proposed a change to both dosage form and
route of administration.
• Old form and name – Narcan injectable
(emergency treatment of known or suspected opioid overdose)
• New form and name- Narcan intranasal
This application represents the first nasal naloxone spray to meet the
criteria for novel naloxone products.
Narcan® Intranasal (naloxone hydrochloride)

7. 1. Applications Covered by Section 505(b)(2) [Internet]. U.S. Food
and Drug Administration. 2021 [cited 24 April 2021]. Available
from: https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/applications-covered-section-505b2
2. Seven Noteworthy 505(b)(2) NDA Submissions | PDG
[Internet]. PDG. 2021 [cited 24 April 2021]. Available from:
https://pharmdevgroup.com/seven-noteworthy-505b2-
submissions/
Reference

8. Thank you…