A Ranibizumab Ocular Implant (Susvimo) for Age-Related Macular Degeneration
Date: May 2, 2022
Issue #:
1649Summary:
The FDA has approvedSusvimo (Genentech), a
refillable permanent ocular implant containing the
vascular endothelial growth factor (VEGF) inhibitor
ranibizumab, for treatment of neovascular (wet) age-related
macular degeneration (nAMD) in patients who
have previously responded to at least two intravitreal
injections of a VEGF inhibitor. Ranibizumab intravitreal
injection (Lucentis) has been available since 2006 for
monthly treatment of nAMD. The FDA has approved
ranibizumab-nuna (Byooviz), a biosimilar of Lucentis
and the first ophthalmologic...
Source: The Medical Letter - April 18, 2022 Category: Drugs & Pharmacology Authors: admin Source Type: research
Vazalore - A New Aspirin Formulation
Date: May 2, 2022
Issue #:
1649Summary:
The FDA has approved an over-the-counter (OTC)
liquid-filled capsule formulation of aspirin (Vazalore–
PLx Pharma). The manufacturer has been heavily
promotingVazalore with claims of fast, predictable
absorption and antiplatelet activity and improved
gastrointestinal safety compared to existing OTC
aspirin formulations. (Source: The Medical Letter)
Source: The Medical Letter - April 5, 2022 Category: Drugs & Pharmacology Authors: admin Source Type: research
COVID-19 Updates
Date: April 18, 2022
Issue #:
1648Summary:
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer-BioNTech(Comirnaty) and
Moderna(Spikevax) to allow for their use as a second
booster dose ≥4 months after a first booster dose in
adults ≥50 years old and in persons aged ≥12 years
(Pfizer) or ≥18 years (Moderna) who have undergone
solid organ transplantation or have a condition that
compromises the immune system to a similar extent. (Source: The Medical Letter)
Source: The Medical Letter - April 1, 2022 Category: Drugs & Pharmacology Authors: admin Tags: bebtelovimab Comirnaty COVID-19 Lagevrio molnupiravir nirmatrelvir Paxlovid remdesivir Ritonavir sotrovimab Spikevax vaccines Veklury Source Type: research
Efgartigimod alfa (Vyvgart) for Myasthenia Gravis
Date: April 18, 2022
Issue #:
1648Summary:
Efgartigimod alfa-fcab (Vyvgart– Argenx), a first-in-class neonatal Fc receptor (FcRn) antagonist,
has been approved by the FDA for IV treatment of
generalized myasthenia gravis in adults who are
anti-acetylcholine receptor (AChR) antibody positive.
The IV complement inhibitor eculizumab(Soliris) was
approved for the same indication in 2017. (Source: The Medical Letter)
Source: The Medical Letter - April 1, 2022 Category: Drugs & Pharmacology Authors: admin Tags: azathioprine cyclosporine corticosteroids eculizumab efgartigimod alfa methotrexate rituximab myasthenia gravis Pyridostigmine Tacrolimus Vyvgart Source Type: research
A Drug-Eluting Contact Lens for Allergic Conjunctivitis
Date: April 18, 2022
Issue #:
1648Summary:
The FDA has approvedAcuvue Theravision with
Ketotifen (Johnson& Johnson Vision Care), a daily-wear,
disposable, vision-correcting soft contact
lens that releases the H1-antihistamine ketotifen, for
prevention of ocular itch due to allergic conjunctivitis
in contact lens users. This is the first approval for a
drug-eluting contact lens. Ketotifen eye drops (Alaway,
Zaditor, and others) are available over the counter. (Source: The Medical Letter)
Source: The Medical Letter - April 1, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Acuvue Theravision Alaway Antihistamines Conjunctivitis corticosteroids Eye Ketotifen loteprednol naphazoline Zaditor Source Type: research
Drugs for Benign Prostatic Hyperplasia
Date: May 2, 2022
Issue #:
1649Summary:
About 60% of men ≥60 years old have clinically
relevant prostatic enlargement due to benign prostatic
hyperplasia (BPH). The goals of treatment are to
decrease lower urinary tract symptoms and to prevent
disease progression and complications such as acute
urinary retention. The American Urologic Association ' s
guidelines for treatment of BPH were recently updated. (Source: The Medical Letter)
Source: The Medical Letter - March 22, 2022 Category: Drugs & Pharmacology Authors: admin Source Type: research
Comparison Table: H2-Receptor Antagonists and PPIs (online only)
Date: April 4, 2022
Issue #:
1647Summary:
View the Comparison Table: H2-Receptor Antagonists and PPIs (Source: The Medical Letter)
Source: The Medical Letter - March 17, 2022 Category: Drugs & Pharmacology Authors: admin Source Type: research
Tramadol/Celecoxib (Seglentis) for Pain
Date: April 18, 2022
Issue #:
1648Summary:
The FDA has approvedSeglentis (Esteve/Kowa), an
oral combination of tramadol hydrochloride, a weak
opioid agonist and weak serotonin and norepinephrine
reuptake inhibitor (SNRI), and celecoxib, a COX-2
selective nonsteroidal anti-inflammatory drug
(NSAID), for use in adults with acute pain that is
severe enough to require an opioid and for which
alternative treatment options are inadequate. (Source: The Medical Letter)
Source: The Medical Letter - March 8, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Acetaminophen Celecoxib Hydrocodone Opioids Oxycodone Pain Seglentis tramadol Source Type: research
Zimhi - A Higher-Dose Injectable Naloxone for Opioid Overdose
Date: April 18, 2022
Issue #:
1648Summary:
The FDA has approved a higher-dose injectable
formulation of the opioid antagonist naloxone
(Zimhi– Adamis) for emergency treatment of opioid
overdose. A single IM or SC injection of the new
formulation delivers 5 mg of naloxone; injectable
formulations that deliver 0.4 mg or 2 mg of the drug
have been available for years. Naloxone is also
available in intranasal formulations for the same
indi cation (see Table 1). (Source: The Medical Letter)
Source: The Medical Letter - March 8, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Drug abuse Kloxxado Naloxone Narcan opioid abuse Opioid dependence Opioids Zimhi Source Type: research
Drugs for GERD and Peptic Ulcer Disease
Date: April 4, 2022
Issue #:
1647Summary:
Gastroesophageal reflux disease (GERD) is the most
common GI condition encountered in the outpatient
setting; it affects about 20% of people in the US. (Source: The Medical Letter)
Source: The Medical Letter - March 8, 2022 Category: Drugs & Pharmacology Authors: admin Source Type: research
COVID-19 Updates
Date: March 21, 2022
Issue #:
1646Summary:
The CDC has issued new guidance allowing for
an interval of up to 8 weeks between the first and
second primary doses of an mRNA COVID-19 vaccine
in certain patients 12-64 years old.1 Product labeling
currently recommends a 3-week interval between the
first two doses of the Pfizer/BioNTech mRNA vaccine(Comirnaty) and a 4-week interval between the first
two doses of the Moderna mRNA vaccine(Spikevax).
The new guidance is based on data suggesting that
a longer interval can decrease the risk of myocarditis
and may improve vaccine efficacy. (...
Source: The Medical Letter - March 4, 2022 Category: Drugs & Pharmacology Authors: admin Tags: cilgavimab Comirnaty COVID-19 Evusheld Spikevax tixagevimab vaccines Source Type: research
Comparison Table: Some Nonopioid Analgesics for Pain (online only)
Date: March 7, 2022
Issue #:
1645Summary:
View the Comparison Table: Some Nonopioid Analgesics for Pain (Source: The Medical Letter)
Source: The Medical Letter - February 18, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Acetaminophen Advil Aleve Anaprox Arthrotec Aspirin Bayer Caldolor Cancer pain Celebrex Celecoxib Codeine Cytotec Diclofenac Diflunisal Duexis Dyloject Esomeprazole etodolac Famotidine Fenoprofen Feverall Flurbi Source Type: research
An EUA for Bebtelovimab for Treatment of COVID-19
Date: March 21, 2022
Issue #:
1646Summary:
The investigational monoclonal antibody
bebtelovimab (LY-CoV1404 – Lilly) has been granted
an FDA Emergency Use Authorization (EUA) for IV
treatment of mild to moderate COVID-19 in patients
≥12 years old who weigh ≥40 kg and are at high
risk of progressing to severe disease, including
hospitalization and death, and for whom alternative
treatment options are unavailable or inappropriate.
Bebtelovimab is active against the Omicron variant of
SARS-CoV-2; sotrovimab (VIR-7831) is the only other
monoclonal antibody currently available ...
Source: The Medical Letter - February 17, 2022 Category: Drugs & Pharmacology Authors: admin Tags: bamlanivimab bebtelovimab COVID-19 etesevimab molnupiravir nirmatrelvir Paxlovid remdesivir Ritonavir sotrovimab Veklury Source Type: research
Faricimab (Vabysmo) for Age-Related Macular Degeneration and Diabetic Macular Edema
Date: March 21, 2022
Issue #:
1646Summary:
Faricimab-svoa (Vabysmo– Genentech), an inhibitor
of both vascular endothelial growth factor (VEGF)
and angiopoietin-2 (Ang-2), has been approved by
the FDA for intravitreal treatment of neovascular
(wet) age-related macular degeneration (nAMD) and
diabetic macular edema (DME). It is the first drug to
become available i n the US that targets two pathways
involved in maintaining vascular homeostasis.
Several VEGF inhibitors are available for treatment of
nAMD and DME (see Table 2). (Source: The Medical Letter)
Source: The Medical Letter - February 8, 2022 Category: Drugs & Pharmacology Authors: admin Tags: aflibercept Age-related macular degeneration Avastin Beovu Bevacizumab brolucizumab Byooviz Eye Eylea faricimab Lucentis Ranibizumab Susvimo Vabysmo Source Type: research
In Brief: Expanded Heart Failure Indication for Empagliflozin (Jardiance)
Date: April 18, 2022
Issue #:
1648Summary:
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance– Boehringer Ingelheim)
was approved by the FDA in 2021 to reduce the
risk of hospitalization for heart failure (HF) and
cardiovascular death in patients with heart failure
with reduced ejection fraction (HFrEF; LVEF ≤40%),
regardless of whether or not they have type 2
diabetes. The indication h as now been expanded to
include patients with HF with any ejection fraction.
Empagliflozin is the first SGLT2 inhibitor to be
approved in the US for this indication....
Source: The Medical Letter - February 8, 2022 Category: Drugs & Pharmacology Authors: admin Tags: canagliflozin dapagliflozin empagliflozin ertugliflozin Farxiga Forxiga Heart Failure Invokana Jardiance Steglatro type 2 diabetes Source Type: research
