Pharmaceutical Outsourcing Q2 2024 - 35
HORIZON LINES: A QUARTERLY REVIEW OF NDAs
SECTION TITLE
HORIZON LINES
A Quarterly Review of NDAs -
January - March 2024
Neelam Sharma MS, Lavanya Kundurthy BE
and Hemant N. Joshi, PhD, MBA#
Tara Innovations LLC
#
hemantjoshi@tarainnovations.com
www.tara-marketing.com
This quarterly review on New Drug Applications contains data for
applications approved during the first quarter of 2024, which includes
New Molecular Entities (NMEs) and new biologics. A total of 28
applications were approved by the FDA during these three months.
The NDAs approved during the first quarter of 2024 have been
divided into nine different dosage forms. Following are the
percentages of those dosage forms - injection (46.4%), tablets
(25%), oral suspension (7.1%), topical gel (7.1%) and capsules, oral
solution, gas, ophthalmic, and tablet for suspension (3.6% each).
Following are the submission classifications:
BLA (23.3%), Type
1 (New Molecular Entity, 20.0%), Type 2 ( New Active Ingredient,
6.7%), Type 3 (New Dosage Form, 20.0%), Type 4 (New Combination,
13.3%), and Type 5 (New Formulation or Manufacturer, 16.7%).
Topical gel Zelsuvmi has been approved by the FDA for use in
patients 1 year and older with molluscum contagiosum. Zelsuvmi
(berdazimer gel 10.3%) releases nitric oxide upon application which
has an antimicrobial effect. It is the first prescription treatment
indicated for the viral infection that mostly affects children.
EOHILIA is a corticosteroid indicated for 12 weeks of treatment
in adult and pediatric patients 11 years of age and older with
eosinophilic esophagitis (EoE).
Aprocitentan, sold under the brand name Tryvio, is a medication
used for the treatment of hypertension (high blood pressure). It is
an endothelin receptor antagonist active at both endothelin A and
endothelin B receptors.
Winrevair is a First-in-Class Treatment for Adults with Pulmonary
Arterial Hypertension (PAH). Following its approval in 2024, the list
price of Winrevair as a single-vial and double-vial kit was announced
at $14,000 per vial, with an estimated annual cost of $240,000 a
year. It was determined that Winrevair would be cost-effective for
treating PAH if priced between $18,700 and $36,200 annually.
Exblifep contains a combination of Cefepime HCl and
Enmetazobactam. Cefepime is a cephalosporin antibacterial.
Enmetazobactam is a beta-lactamase inhibitor. Enmetazobactam
was first invented in India by Orchid Pharma and then out-licensed
to Allecra Therapeutics (Patent #7687488B2).
pharmoutsourcing.com | 35 | April/May/June 2024
http://www.tara-marketing.com
http://www.pharmoutsourcing.com
Pharmaceutical Outsourcing Q2 2024
Table of Contents for the Digital Edition of Pharmaceutical Outsourcing Q2 2024
EDITOR'S MESSAGE
EDITORIAL ADVISORY BOARD
SUPPLY CHAIN - Six of the Best Methods to Spark Distribution Improvement and Innovation for the Next Decade
CLINICAL TRIALS - Toward More Intelligent Collaboration: Implementing Data in Partnerships
CLINICAL TRIALS - Leveraging Machine Learning and Deep Learning for Natural Language Processing in Clinical Data Management
CLINICAL TRIALS - Beat the Clock: How an FSP Model Can Optimize a Follow-the-Sun Approach in Clinical Development Functions
CONTRACT RESEARCH - Elevating Laboratory and Manufacturing Equipment Health With AI-Predicted Health Score
AN INTERVIEW WITH GIANMARCO NEGRISOLI, FLAMMA USA
ROUNDTABLE - Pediatric Dosage Forms
SUPPLY CHAIN - Navigating Trends and Challenges Facing Pharmaceutical Supply Chains
HORIZON LINES
INDUSTRY NEWS
ADVERTISER'S INDEX
Pharmaceutical Outsourcing Q2 2024 - Cover1
Pharmaceutical Outsourcing Q2 2024 - Cover2
Pharmaceutical Outsourcing Q2 2024 - 1
Pharmaceutical Outsourcing Q2 2024 - EDITOR'S MESSAGE
Pharmaceutical Outsourcing Q2 2024 - 3
Pharmaceutical Outsourcing Q2 2024 - 4
Pharmaceutical Outsourcing Q2 2024 - 5
Pharmaceutical Outsourcing Q2 2024 - EDITORIAL ADVISORY BOARD
Pharmaceutical Outsourcing Q2 2024 - 7
Pharmaceutical Outsourcing Q2 2024 - SUPPLY CHAIN - Six of the Best Methods to Spark Distribution Improvement and Innovation for the Next Decade
Pharmaceutical Outsourcing Q2 2024 - 9
Pharmaceutical Outsourcing Q2 2024 - 10
Pharmaceutical Outsourcing Q2 2024 - 11
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Toward More Intelligent Collaboration: Implementing Data in Partnerships
Pharmaceutical Outsourcing Q2 2024 - 13
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Leveraging Machine Learning and Deep Learning for Natural Language Processing in Clinical Data Management
Pharmaceutical Outsourcing Q2 2024 - 15
Pharmaceutical Outsourcing Q2 2024 - 16
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Beat the Clock: How an FSP Model Can Optimize a Follow-the-Sun Approach in Clinical Development Functions
Pharmaceutical Outsourcing Q2 2024 - 18
Pharmaceutical Outsourcing Q2 2024 - 19
Pharmaceutical Outsourcing Q2 2024 - CONTRACT RESEARCH - Elevating Laboratory and Manufacturing Equipment Health With AI-Predicted Health Score
Pharmaceutical Outsourcing Q2 2024 - 21
Pharmaceutical Outsourcing Q2 2024 - 22
Pharmaceutical Outsourcing Q2 2024 - 23
Pharmaceutical Outsourcing Q2 2024 - AN INTERVIEW WITH GIANMARCO NEGRISOLI, FLAMMA USA
Pharmaceutical Outsourcing Q2 2024 - 25
Pharmaceutical Outsourcing Q2 2024 - ROUNDTABLE - Pediatric Dosage Forms
Pharmaceutical Outsourcing Q2 2024 - 27
Pharmaceutical Outsourcing Q2 2024 - 28
Pharmaceutical Outsourcing Q2 2024 - 29
Pharmaceutical Outsourcing Q2 2024 - 30
Pharmaceutical Outsourcing Q2 2024 - 31
Pharmaceutical Outsourcing Q2 2024 - SUPPLY CHAIN - Navigating Trends and Challenges Facing Pharmaceutical Supply Chains
Pharmaceutical Outsourcing Q2 2024 - 33
Pharmaceutical Outsourcing Q2 2024 - 34
Pharmaceutical Outsourcing Q2 2024 - HORIZON LINES
Pharmaceutical Outsourcing Q2 2024 - 36
Pharmaceutical Outsourcing Q2 2024 - 37
Pharmaceutical Outsourcing Q2 2024 - INDUSTRY NEWS
Pharmaceutical Outsourcing Q2 2024 - 39
Pharmaceutical Outsourcing Q2 2024 - ADVERTISER'S INDEX
Pharmaceutical Outsourcing Q2 2024 - Cover3
Pharmaceutical Outsourcing Q2 2024 - Cover4
https://www.nxtbookmedia.com