PharmaceuticalOutsourcingQ42020 - 54



A Quarterly Review of NDAs -
July-September 2020

Neelam Sharma, MS and
Hemant N. Joshi, PhD, MBA#

Ptosis can limit or even completely block normal vision. Upneeq
contains oxymetazoline HCl and it is the only treatment approved
to treat Ptosis.

Tara Innovations LLC
This quarterly review on New Drug Applications (NDAs) contains
data for applications approved for the first-time during JulySeptember 2020, which includes New Molecular Entities (NMEs) and
new biologics. A total of 36 applications were approved by the FDA
during these three months.
Following are the percentage of various dosage forms in this
quarter-13.9% tablets, 11.1% oral liquids, 47.2% injectables, 5.6%
capsules, 8.3% topical, and 13.9% other dosage forms. Other
dosage forms include - ophthalmic drops, gas inhalation, metered
dose aerosol and implants. Based on the submission classification,
the NDAs can be divided as follows: new molecular entity (Type 1)
- 40.7%, new active ingredient (Type 2) - 3.7%, new dosage form
(Type 3) - 22.2%, new combination (Type 4) - 11.1% and new
formulation or manufacturer (Type 5) - 22.2%.
Tralement™ is the first and only FDA approved multi-trace element
injection. Each mL contains zinc 3 mg, copper 0.3 mg, manganese
55 mcg and selenium 60 mcg. Tralement™ is recommended only for
patients who require supplementation with all four of the individual
trace elements (i.e., zinc, copper, manganese, and selenium).
Cellulite is the dimpled-looking skin that commonly occurs in the
thigh region. It forms when fatty tissue deep in the skin pushes
up against connective tissue. It is estimated that more than 85
percent of all women 21 years and older have cellulite. Qwo™
contains collagenase clostridium histolyticum-aaes and it is the first
treatment for cellulite.
Ptosis is when the upper eyelid droops over the eye. The eyelid
may droop just a little, or so much that it covers the pupil.
Pharmaceutical Outsourcing |


Abametapir is a novel pediculicidal metalloproteinase inhibitor used
to treat infestations of head lice. The life cycle of head lice (Pediculus
capitis) is approximately 30 days, seven to twelve of which are spent
as eggs laid on hair shafts near the scalp. Several metalloproteinase
enzymes are critical to the egg hatching and survival of head lice,
and abametapir is an inhibitor of these metalloproteinase enzymes
(Xeglyze). The improved ovicidal activity (90-100% in vitro) of
abametapir allows for a single administration, in contrast to many
other topical treatments.
FDA granted accelerated approval to Viltepso® injection for the
treatment of Duchenne muscular dystrophy (DMD) in patients who
have a confirmed mutation of the DMD gene that is susceptible
to exon 53 skipping. DMD is a rare genetic disorder. It is the most
common type of muscular dystrophy. DMD is caused by mutations
in the DMD gene that results in an absence of dystrophin, a protein
that helps keep muscle cells intact. Viltolarsen is an antisense
oligonucleotide drug that binds to exon 53 of dystrophin premRNA and excludes the exon in patients with genetic mutations
susceptible to exon 53 skipping during mRNA processing. Exon
53 skipping is intended to allow the production of an internal
dystrophin protein in patients with genetic mutations susceptible
to exon 53.
Alkindi Sprinkle is the first and only FDA-approved granular
hydrocortisone formulation for the treatment of Pediatric
Adrenocortical Insufficiency. Adrenal insufficiency is a condition
in which the adrenal glands do not produce adequate amounts
of cortisol and is often caused by Addison's disease or Congenital
Adrenal Hyperplasia (CAH). Insufficient levels of cortisol in children
may cause delayed or stunted physical development, reproductive
irregularities, and can be potentially fatal.
| October/November/December 2020


Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4