PO Q1 2021 - 45
HORIZON LINES: A QUARTERLY REVIEWSECTION
OF NDAs
TITLE
Approval
date
Drug name
Active ingredients
Submission classification
Company
Type of dosage form/
route
Comments
10/6/2020
Dolutegravir, lamivudine and tenofovir
disoproxil fumarate
Dolutegravir; lamivudine;
tenofovir disoproxil
fumarate
Type 4 - New Combination
Shanghai Desano Biopharmaceuticals Co Ltd.
Tablet; oral
Fixed dose combination
antiretroviral medication to
treat HIV-1.
10/14/2020
Inmazeb
Atoltivimab; odesivimab;
maftivimab
BLA
Regeneron
Pharmaceuticals
Solution; injection
First FDA-approved treatment for
Zaire ebolavirus (Ebola virus).
10/16/2020
Ephedrine sulfate
Ephedrine sulfate
Type 5 - New Formulation
or New Manufacturer
Endo Ventures
Solution; intravenous
The first and only FDA-approved,
ready-to-use ephedrine injection.
10/20/2020
Esomeprazole
magnesium
Esomeprazole magnesium
Type 3 - New Dosage Form
Dexcel Pharma
Tablet, orally
Delayed release orally disintegrating
disintegrating,
tablets for the treatment of
delayed release; oral
frequent heartburn in adults.
10/22/2020
Veklury
Remdesivir
Type 1 New Molecular Entity
Gilead Sciences Inc.
Powder; intravenous
and solution;
intravenous
First drug approved to treat
COVID-19.
10/26/2020
Eysuvis
Loteprednol etabonate
Type 10 - New Indication
Submitted as Distinct NDA Not Consolidated
Kala Pharma, Inc.
Suspension/drops;
ophthalmic
First ocular corticosteroid for the
treatment of dry-eye disease.
10/30/2020
Bronchitol
Mannitol
Type 10 - New Indication
Submitted as Distinct NDA Not Consolidated
Chiesi
Powder; inhalation
The first and only inhaled dry powder to improve pulmonary function
in cystic fibrosis (CF) patients.
Sedor Pharma LLC
The first and only FDA-approved
room temperature stable
Solution; intravenous
fosphenytoin for the treatment of
status Epilepticus.
11/05/2020
Sesquient
Fosphenytoin sodium
Type 5 - New Formulation
or New Manufacturer
11/09/2020
Labetalol hydrochloride in dextrose
Labetalol hydrochloride
Type 5 - New Formulation
or New Manufacturer
Hikma
Solution; intravenous
Beta adrenergic blocker; used in
severe hypertension.
11/09/2020
Labetalol hydrochloride in sodium chloride
Labetalol hydrochloride
Type 5 - New Formulation
or New Manufacturer
Hikma
Solution; intravenous
Beta adrenergic blocker; used in
severe hypertension.
11/10/2020
Sutab (copackaged)
Magnesium sulfate;
potassium chloride;
sodium sulfate
Type 3 - New Dosage Form
Braintree Labs
Tablet; oral
The first tablet colonoscopy
preparation.
11/19/2020
Dolutegravir
Dolutegravir
Type 3 - New Dosage Form
Mylan Labs, Ltd.
Tablet; oral
First integrase inhibitor as a dispersible tablet for oral suspension
for children weighing at least 3kg
and from four weeks of age.
Lonafarnib
Type 1 - New Molecular
Entity
Eiger BioPharma
Capsule; oral
To treat Hutchinson-Gilford
progeria syndrome and processingdeficient progeroid laminopathies
in patients ages 1 and above.
Alnylam Pharma Inc.
Solution;
subcutaneous
The first and only prescription
medication for the treatment
of primary hyperoxaluria type 1
(PH1) to lower oxalate in urine.
11/20/2020
Zokinvy
11/23/2020
Oxlumo
Lumasiran sodium
Type 1 - New Molecular
Entity
11/23/2020
Xofluza
Baloxavir marboxil
Type 3 - New Dosage Form
Genentech Inc.
For suspension; oral
First single dose, post-exposure
preventive treatment for influenza.
11/25/2020
Micafungin sodium
Micafungin sodium
Type 5 - New Formulation
or New Manufacturer
Teva Pharma USA
Injectable;
intravenous
Tentative approval, final approval
subject to expiration of period of
patent protection.
Setmelanotide acetate
Type 1 New Molecular Entity
Rhythm
Solution;
subcutaneous
The first-ever FDA approved
therapy for patients suffering with
obesity due to genetic diseases like
POMC, PCSK1 or LEPR deficiency.
11/25/2020
Imcivree
pharmoutsourcing.com |
45
| January/February/March 2021
http://www.pharmoutsourcing.com
PO Q1 2021
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