Pemigatinib (Pemazyre) for Cholangiocarcinoma (online only)
Date: December 28, 2020
Issue #:
1614Summary:
The oral kinase inhibitor pemigatinib (Pemazyre –
Incyte) has received accelerated approval from
the FDA for treatment of adults with previously
treated, unresectable, locally advanced or metastatic
cholangiocarcinoma with fibroblast growth factor
receptor 2 (FGFR2) fusions or other rearrangements.
Pemigatinib is the first drug to be approved i n the US
for this indication. (Source: The Medical Letter)
Source: The Medical Letter - December 22, 2020 Category: Drugs & Pharmacology Authors: admin Source Type: research
FDA Authorizes Moderna COVID-19 Vaccine
Date: January 25, 2021
Issue #:
1616Summary:
On December 18, 2020, the FDA issued an Emergency
Use Authorization (EUA) for the Moderna mRNA-based
vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based
vaccine received an FDA EUA for the same indication
in persons ≥16 years old on December 11, 2020. (Source: The Medical Letter)
Source: The Medical Letter - December 22, 2020 Category: Drugs & Pharmacology Authors: admin Tags: COVID-19 vaccines Source Type: research
Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis
Date: January 11, 2021
Issue #:
1615Summary:
The FDA has approvedGimoti (Evoke), a nasal
spray formulation of the dopamine-2 (D2) receptor
antagonist metoclopramide, for relief of symptoms in
adults with acute and recurrent diabetic gastroparesis.
Metoclopramide (Reglan, and generics) has been
available for years in conventional and orally-disintegrating
tablets and in an injectable formulation.
It is the only drug that is FDA-approved for treatment
of diabetic gastroparesis. (Source: The Medical Letter)
Source: The Medical Letter - December 18, 2020 Category: Drugs & Pharmacology Authors: admin Tags: Antibacterials Azithromycin diabetic gastroparesis Domperidone Erythromycin Gimoti Metoclopramide Motilium ondansetron Promethazine Reglan Scopolamine Source Type: research
Opicapone (Ongentys) - A COMT Inhibitor for Parkinson's Disease
Date: January 11, 2021
Issue #:
1615Summary:
The FDA has approved opicapone (Ongentys–
Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an
adjunct to carbidopa/levodopa in adults with Parkinson’s
disease (PD) who experience " off " episodes. It is the
third COMT inhibitor to be approved for this indication;
tolcapone (Tasmar, and generics) and entacapone
(Comtan, and generics) were approved earlier. Opicapone
has been available in Europe since 2016. (Source: The Medical Letter)
Source: The Medical Letter - December 18, 2020 Category: Drugs & Pharmacology Authors: admin Tags: Apokyn Apomorphine Carbidopa/levodopa Comtan Dopamine Entacapone Epinephrine Inbrija istradefylline Kynmobi Movapo Nourianz Ongentys opicapone Parkinson ' s disease Phenelzine Rytary selegeline Stalevo Tasmar To Source Type: research
Baloxavir (Xofluza) for Post-Exposure Prophylaxis of Influenza
Date: January 11, 2021
Issue #:
1615Summary:
The oral polymerase acidic endonuclease inhibitor
baloxavir marboxil (Xofluza— Genentech) is now FDAapproved
for post-exposure prophylaxis of influenza
in patients ≥12 years old. Baloxavir was approved for
treatment of acute uncomplicated influenza in patients
≥12 years old in 2018.1 Two neuraminidase inhibitors
are FDA-approved for prophylaxis of influenza:
oseltamivi r(Tamiflu, and generics) in patients ≥1 year
old, and zanamivir(Relenza) in patients ≥5 years old.2
Unlike oseltamivir and zanamivir, baloxavir is not FDA-appr...
Source: The Medical Letter - December 18, 2020 Category: Drugs & Pharmacology Authors: admin Tags: baloxavir influenza Oseltamivir Relenza Tamiflu Xofluza Zanamivir Source Type: research
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine
Date: January 11, 2021
Issue #:
1615Summary:
The FDA has issued an Emergency Use Authorization
(EUA) for the Pfizer-BioNTech mRNA-based vaccine
for prevention of COVID-19 in persons≥16 years old. (Source: The Medical Letter)
Source: The Medical Letter - December 18, 2020 Category: Drugs & Pharmacology Authors: admin Tags: COVID-19 vaccines Source Type: research
An EUA for Baricitinib (Olumiant) for COVID-19
Date: December 28, 2020
Issue #:
1614Summary:
The oral Janus kinase (JAK) inhibitor baricitinib
(Olumiant– Lilly) has been granted an FDA Emergency
Use Authorization (EUA) for treatment of confirmed or
suspected COVID-19 in hospitalized patients ≥2 years
old who require supplemental oxygen, mechanical
ventilation, or extracorporeal membrane oxygenation
(ECMO); the EUA requires that baricitinib be u sed
in combination with the IV antiviral drug remdesivir(Veklury). Baricitinib has been available for treatment
of rheumatoid arthritis since 2018. Remdesivir was
recently approved...
Source: The Medical Letter - December 11, 2020 Category: Drugs & Pharmacology Authors: admin Tags: baricitinib COVID-19 Oluminat remdesivir Veklury Source Type: research
Antibacterial Drugs for Community-Acquired Pneumonia
Date: January 25, 2021
Issue #:
1616Summary:
Treatment of community-acquired pneumonia (CAP)
is usually empiric, with selected antibiotic regimens
directed against some of the most common causative
pathogens. Recommended empiric regimens are
listed in Table 2; recommended antibiotic dosages for
treatment of CAP are listed in Tables 3 and 4. Joint
guidelines for treatment of CAP by the American
Thoracic Society and the Infectious Diseases Society of
America (ATS/IDSA) were updated in 2019. (Source: The Medical Letter)
Source: The Medical Letter - December 4, 2020 Category: Drugs & Pharmacology Authors: admin Tags: Amoxicillin Amoxicillin/clavulanate Ampicillin/sulbactam Antibacterials Avelox Azithromycin Baxdela Biaxin cefepime Cefotaxime Cefpodoxime ceftaroline Ceftin Ceftriaxone Cefuroxime Chlamydophila pneumoniae Clarithromycin Source Type: research
Correct Use of Inhalers for Asthma (online only)
Date: December 14, 2020
Issue #:
1613Summary:
View the table: Correct Use of Inhalers for Asthma (Source: The Medical Letter)
Source: The Medical Letter - December 4, 2020 Category: Drugs & Pharmacology Authors: admin Source Type: research
Some Inhaled Drugs for Treatment of Asthma (online only)
Date: December 14, 2020
Issue #:
1613Summary:
View the table: Some Inhaled Drugs for Treatment of Asthma (Source: The Medical Letter)
Source: The Medical Letter - December 4, 2020 Category: Drugs & Pharmacology Authors: admin Source Type: research
An EUA for Casirivimab and Imdevimab for COVID-19
Date: December 28, 2020
Issue #:
1614Summary:
The FDA has issued an Emergency Use Authorization
(EUA) for Regeneron ' s investigational monoclonal
antibodies casirivimab (REGN10933) and imdevimab
(REGN10987) to be administered together by IV
infusion for treatment of mild to moderate COVID-19
in adults and pediatric patients ( ≥12 years old and
weigh ≥40 kg) who are at high risk of progressing to
severe COVID-19 and/or hospitalization (see Table 1).
Bamlanivimab (LY-CoV555; Lilly), another monoclonal
antibody, received an EUA for the same indication on
November 9, 2020. (Sou...
Source: The Medical Letter - November 24, 2020 Category: Drugs & Pharmacology Authors: admin Tags: casirivimab COVID-19 imdevimab Source Type: research
Drugs for Acne
Date: November 30, 2020
Issue #:
1612Summary:
Acne is common among adolescents and young adults,
but its prevalence appears to have increased in people
of all ages due to prolonged wearing of masks during
the COVID-19 pandemic. Guidelines for treatment of
acne were last published in 2016. (Source: The Medical Letter)
Source: The Medical Letter - November 20, 2020 Category: Drugs & Pharmacology Authors: admin Source Type: research
An EUA for Bamlanivimab - A Monoclonal Antibody for COVID-19
Date: November 30, 2020
Issue #:
1612Summary:
The investigational neutralizing IgG1 monoclonal
antibody bamlanivimab (LY-CoV555; Lilly) has
been granted an FDA Emergency Use Authorization
(EUA) for treatment of recently diagnosed mild
to moderate COVID-19 in patients who are ≥12
years old, weigh at least 40 kg, and are at high
risk for progressing to severe disease and/or
hospitalization (see Table 1). (Source: The Medical Letter)
Source: The Medical Letter - November 20, 2020 Category: Drugs & Pharmacology Authors: admin Source Type: research
In Brief: New Meningococcal Serogroup B Vaccination Recommendations
Date: November 30, 2020
Issue #:
1612Summary:
The Advisory Committee on Immunization Practices
(ACIP) has issued new recommendations for meningococcal
vaccination. Booster vaccination against
Neisseria meningitidis serogroup B (MenB) is
now recommended in persons at increased risk
for meningococcal disease (see Table 1). MenB
booster doses were not recommended previously for
any population. (Source: The Medical Letter)
Source: The Medical Letter - November 10, 2020 Category: Drugs & Pharmacology Authors: admin Source Type: research
Ofatumumab (Kesimpta) for Multiple Sclerosis
Date: December 28, 2020
Issue #:
1614Summary:
The FDA has approved a subcutaneous formulation
of the recombinant human anti-CD20 antibody
ofatumumab (Kesimpta– Novartis) for treatment
of adults with relapsing forms of multiple sclerosis
(MS), including clinically isolated syndrome (initial
neurological episode), relapsing-remitting disease,
and active secondary progressive MS (SPMS).Kesimpta is the second anti-CD20 antibody to be
approved for these indications; IV ocrelizumab(Ocrevus), which is also approved for treatment
of primary progressive MS, was the first. An IV
formulat...
Source: The Medical Letter - November 10, 2020 Category: Drugs & Pharmacology Authors: admin Tags: Arzerra COVID-19 Kesimpta Multiple sclerosis ocrelizumab Ocrevus Ofatumumab teriflunomide Source Type: research
