Ruxolitinib (Opzelura) for Atopic Dermatitis
Date: January 24, 2022
Issue #:
1642Summary:
The FDA has approved a 1.5% topical cream
formulation of the Janus kinase (JAK) inhibitor
ruxolitinib (Opzelura– Incyte) for short-term, non-continuous
chronic treatment of mild to moderate
atopic dermatitis (AD) in non-immunocompromised
patients≥12 years old whose disease has not been
adequately controlled with other topical prescription
drugs. Ruxolitinib is the first JAK inhibitor to be
approved for topical use and the first to be approved
in the US for treatment of AD. An oral formulation
of ruxolitinib(Jakafi) is approved for...
Source: The Medical Letter - December 10, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Atopic dermatitis corticosteroids crisaborole Elidel Eucrisa Jakafi Jakavi Opzelura Pimecrolimus Protopic ruxolitinib Tacrolimus tofacitinib Xeljanz Source Type: research
Bupivacaine/Meloxicam (Zynrelef) for Postsurgical Pain
Date: January 24, 2022
Issue #:
1642Summary:
The FDA has approved a fixed-dose combination
of the amide local anesthetic bupivacaine and
the nonsteroidal anti-inflammatory drug (NSAID)
meloxicam as an extended-release (ER) solution
(Zynrelef– Heron) for single-dose, intraoperative,
soft-tissue or periarticular instillation to provide
postsurgical analgesia for up to 72 hours in adults
undergoing foot and ankle, small-to-medium open
abdominal, or lower extremity total joint arthroplasty
surgical procedures. (Source: The Medical Letter)
Source: The Medical Letter - December 10, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Acetaminophen Bupivacaine Exparel Meloxicam NSAIDs Opioids ropivacaine Zynrelef Source Type: research
Xywav - A Mixed-Salt Oxybate Oral Solution for Idiopathic Hypersomnia
Date: December 27, 2021
Issue #:
1640Summary: Xywav (Jazz), an oral solution that contains calcium,
magnesium, potassium, and sodium oxybates, has
been approved by the FDA for treatment of idiopathic
hypersomnia in adults. It is the first drug to be
approved in the US for this indication.Xywav was
approved in 2020 for treatment of excessive daytime
sleepiness or cataplexy in patients ≥7 years old with
narcolepsy. It contains about 92% less sodium than
sodium oxybate oral solution(Xyrem), which has
been available in the US for years for use in patients ≥7 years old with narcolepsy. (Sour...
Source: The Medical Letter - December 10, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Alertec armodafinil Methylphenidate Narcolepsy Nuvigil pitolisant Provigil Ritalin Sodium oxybate solriamfetol Sunosi Wakix Xyrem Xywav Source Type: research
Clascoterone Cream (Winlevi) for Acne
Date: December 27, 2021
Issue #:
1640Summary:
The FDA has approvedWinlevi (Sun), a 1% cream
formulation of the androgen receptor inhibitor
clascoterone, for treatment of acne vulgaris in
patients ≥12 years old. It is the first topical androgen
receptor inhibitor to be approved by the FDA. (Source: The Medical Letter)
Source: The Medical Letter - December 10, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Acanya Acne Aczone Adapalene Aklief Altreno Amzeeq Antibacterials Arazlo Atralin Avita Azelaic acid Azelex Benzaclin Benzamycin Benzoyl peroxide Biacna clascoterone Cleocin Clindamycin Clindoxy Dalacin Dapsone Source Type: research
Drugs for Acute Otitis Media in Children
Date: February 7, 2022
Issue #:
1643Summary:
More antibiotics are prescribed for treatment of acute
otitis media (AOM) than for any other infection in
young children. Children with AOM typically present
with otalgia, fever, and bulging and erythema of the
tympanic membrane. (Source: The Medical Letter)
Source: The Medical Letter - November 30, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Acetaminophen Amoxicillin Amoxicillin/clavulanate Augmentin Azithromycin Cefdinir Cefpodoxime Ceftriaxone Cefuroxime Clavulin Clindamycin Haemophilus influenzae Ibuprofen Otitis media Streptococcus pneumoniae Zithromax Source Type: research
A New Dihydroergotamine Nasal Spray (Trudhesa) for Migraine
Date: December 27, 2021
Issue #:
1640Summary:
The FDA has approvedTrudhesa (Impel Neuropharma),
a new dihydroergotamine nasal spray
product, for acute treatment of migraine with or
without aura in adults. Another dihydroergotamine
nasal spray (Migranal, and generics) has been
available for many years for the same indication. (Source: The Medical Letter)
Source: The Medical Letter - November 30, 2021 Category: Drugs & Pharmacology Authors: admin Tags: D.H.E. 45 Dihydroergotamine lasmiditan Migraine Migranal Nurtec Reyvow rimegepant Trudhesa Ubrelvy ubrogepant Source Type: research
In Brief: Booster Doses of mRNA-Based COVID-19 Vaccines for All Adults
Date: December 27, 2021
Issue #:
1640Summary:
On November 19, the FDA expanded the Emergency Use
Authorizations (EUAs) for the mRNA-based COVID-19
vaccines manufactured by Pfizer/BioNTech(Comirnaty)
and Moderna(Spikevax) to include administration
of a booster dose for all adults ≥18 years old after
primary immunization with either the same COVID-19
vaccine or a different one. Booster doses of these
vaccines were previously authorized only for select
populations (age ≥65 years or persons at high risk for
severe COVID-19). The EUA for the adenovirus-based
vaccine manufact ured ...
Source: The Medical Letter - November 22, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Flowchart: Rheumatoid Arthritis Treatment (online only)
Date: November 15, 2021
Issue #:
1637Summary:
View the Flowchart: Rheumatoid Arthritis Treatment (Source: The Medical Letter)
Source: The Medical Letter - November 22, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Abatacept Actemra Adalimumab Amgevita Avsola baricitinib Brenzys Certolizumab Cimzia Enbrel Erelzi Etanercept Golimumab Hadlima Hulio Humira Hyrimoz Idacio Inflectra Infliximab Kevzara Olumiant Orencia Remicad Source Type: research
In Brief: Abemaciclib (Verzenio) for Early Breast Cancer
Date: December 13, 2021
Issue #:
1639Summary:
The oral cyclin-dependent kinase (CDK) 4/6 inhibitor
abemaciclib (Verzenio– Lilly), which was approved
by the FDA in 2017 for treatment of hormone receptor
(HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative advanced or metastatic
breast cancer, has now been approved for use in
combination with endocrine therapy (tamoxifen or
an aromatase inhibitor) for adjuvant treatment of
patients with HR-positive, HER2-negative, node-positive,
early breast cancer at high risk of recurrence
and a Ki-67 score≥20%. (Source: The Medical Letter)
Source: The Medical Letter - November 18, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Varenicline Nasal Spray (Tyrvaya) for Dry Eye Disease
Date: December 13, 2021
Issue #:
1639Summary: Tyrvaya (Oyster Point), a nasal spray formulation
of the cholinergic agonist varenicline, has been
approved by the FDA for treatment of dry eye disease.
It is the first nasal spray to be approved in the US
for this indication. An oral formulation of varenicline
(Chantix, and generics) has been available for years
for smoking cessation. (Source: The Medical Letter)
Source: The Medical Letter - November 15, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Children 5-11 Years Old
Date: November 29, 2021
Issue #:
1638Summary:
The FDA has issued an Emergency Use Authorization
(EUA) for a lower-strength (10 mcg/0.2 mL) formulation
of the mRNA-based COVID-19 vaccine
manufactured by Pfizer/BioNTech(Comirnaty) for use
in children 5-11 years old. The original formulation
of(Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for
use in persons ≥16 years old and available under an
EUA for use in adolescents 12-15 years old. (Source: The Medical Letter)
Source: The Medical Letter - November 3, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Booster Doses of COVID-19 Vaccines
Date: November 29, 2021
Issue #:
1638Summary:
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech(Comirnaty) and
Moderna(Spikevax) and the adenovirus-based vaccine
manufactured by Johnson& Johnson/Janssen to
include administration of a booster dose in select
populations after primary immunization with either the
same COVID-19 vaccine or a different one. (Source: The Medical Letter)
Source: The Medical Letter - October 29, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis (online only)
Date: November 15, 2021
Issue #:
1637Summary:
View Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis (Source: The Medical Letter)
Source: The Medical Letter - October 29, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Expanded Table: Some Conventional DMARDs for Rhematoid Arthritis (online only)
Date: November 15, 2021
Issue #:
1637Summary:
View Expanded Table: Some Conventional DMARDs for Rhematoid Arthritis (Source: The Medical Letter)
Source: The Medical Letter - October 29, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Drugs for Rheumatoid Arthritis
Date: November 15, 2021
Issue #:
1637Summary:
Rheumatoid arthritis (RA) is prevalent in 0.5% of
adults in the US; it is about 2.5 times more common
in women than in men. Guidelines for treatment
of RA from the American College of Rheumatology
were recently updated. The goal of treatment is to
minimize disease activity and prevent irreversible
joint damage. (Source: The Medical Letter)
Source: The Medical Letter - October 29, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
