Estetrol/Drospirenone (Nextstellis) - A New Combination Oral Contraceptive
Date: June 28, 2021
Issue #:
1627Summary:
The FDA has approved a combination oral
contraceptive containing the estrogen estetrol and the
progestin drospirenone (Nextstellis– Mithra/Mayne).
Estetrol is the first new estrogen to become available
in the US in 50 years. Drospirenone is available alone(Slynd) and in combinations with the estrogen ethinyl
estradiol for prevention of pregnancy. (Source: The Medical Letter)
Source: The Medical Letter - May 19, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Drospirenone estetrol Estrogens etonogestrel Medroxyprogesterone Nexplanon Nextstellis Oral contraceptives Progestins Slynd Source Type: research
Viloxazine ER (Qelbree) for ADHD
Date: June 28, 2021
Issue #:
1627Summary:
The FDA has approved viloxazine extended-release
capsules (Qelbree– Supernus) for treatment of
attention-deficit/hyperactivity disorder (ADHD) in
children 6-17 years old. Viloxazine is the second
selective norepinephrine reuptake inhibitor to be
approved in the US for treatment of ADHD; atomoxetine
(Strattera, and generics) was approved in 2002. (Source: The Medical Letter)
Source: The Medical Letter - May 19, 2021 Category: Drugs & Pharmacology Authors: admin Tags: ADHD Amphetamine Atomoxetine Clonidine Guanfacine Methylphenidate Qelbree Stimulants Strattera viloxazine Source Type: research
Viloxazine (Qelbree) for ADHD
Date: June 28, 2021
Issue #:
1627Summary:
The FDA has approved viloxazine extended-release
capsules (Qelbree– Supernus) for treatment of
attention-deficit/hyperactivity disorder (ADHD) in
children 6-17 years old. Viloxazine is the second
selective norepinephrine reuptake inhibitor to be
approved in the US for treatment of ADHD; atomoxetine
(Strattera, and generics) was approved in 2002. (Source: The Medical Letter)
Source: The Medical Letter - May 19, 2021 Category: Drugs & Pharmacology Authors: admin Tags: ADHD Amphetamine Atomoxetine Clonidine Guanfacine Methylphenidate Qelbree Stimulants Strattera viloxazine Source Type: research
In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Adolescents 12-15 Years Old
Date: May 31, 2021
Issue #:
1625Summary:
On May 10, 2021, the FDA expanded its Emergency
Use Authorization (EUA) for the Pfizer/BioNTech
mRNA-based COVID-19 vaccine to include adolescents
12-15 years old.1The vaccine has been
authorized for use in persons ≥16 years old since
December 2020. (Source: The Medical Letter)
Source: The Medical Letter - May 11, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Teprotumumab (Tepezza) for Thyroid Eye Disease
Date: May 31, 2021
Issue #:
1625Summary:
Teprotumumab-trbw (Tepezza - Horizon), an insulin-like
growth factor-1 receptor (IGF-1R) inhibitor, has
been approved by the FDA for IV treatment of thyroid
eye disease. It is the first drug to be approved in the US
for this indication. (Source: The Medical Letter)
Source: The Medical Letter - May 4, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Inhaled Mannitol (Bronchitol) for Cystic Fibrosis
Date: May 31, 2021
Issue #:
1625Summary:
The FDA has approved mannitol powder for oral
inhalation (Bronchitol– Chiesi) as add-on maintenance
treatment to improve pulmonary function in adults with
cystic fibrosis (CF). This product has been available in
Europe for the same indication since 2012. Another
formulation of mannitol inhalation powder(Aridol)
is approved in the US for assessment of bronchial
hyperresponsiveness. (Source: The Medical Letter)
Source: The Medical Letter - May 4, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Tramadol Oral Solution (Qdolo) for Pain
Date: May 31, 2021
Issue #:
1625Summary:
The opioid agonist tramadol is now available in an oral
solution (Qdolo– Athena Bioscience) for management
of pain severe enough to require an opioid and for
which alternative treatment options are inadequate.
Tramadol has been available for years in immediate-release
tablets and capsules, extended-release
capsules (Ultram, and others), and in a fixed-dose
combination tablet with acetaminophen (Ultracet,
and generics). (Source: The Medical Letter)
Source: The Medical Letter - May 4, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Cabotegravir/Rilpivirine (Cabenuva) for HIV-1 Infection
Date: May 31, 2021
Issue #:
1625Summary:
The FDA has approvedCabenuva (ViiV Healthcare),
an extended-release formulation of the new integrase
strand transfer inhibitor (INSTI) cabotegravir
copackaged with an extended-release formulation
of the non-nucleoside reverse transcriptase inhibitor
(NNRTI) rilpivirine, as a once-monthly complete
regimen for intramuscular (IM) treatment of adults
with HIV-1 infection who are virologically suppressed
(HIV-1 RNA<50 copies/mL) on a stable antiretroviral
(ARV) regimen, have no history of treatment failure,
and have no known or suspected res...
Source: The Medical Letter - May 4, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
In Brief: Suspension of Johnson & Johnson COVID-19 Vaccine Lifted (online only)
Date: May 17, 2021
Issue #:
1624Summary:
On April 23, 2021, on advice from the Advisory
Committee on Immunization Practices (ACIP), the
FDA and CDC recommended that use of the Johnson& Johnson adenovirus-based COVID-19 vaccine
resume despite its association with development of
thrombosis with thrombocytopenia syndrome (TTS).
Administration of the vaccine had been paused on April
13 because of 6 reports of TTS, but after completing a
data review that identified a further 9 cases associated
with the formulation, the agencies concluded that the
benefits of the vaccine outweighed its...
Source: The Medical Letter - April 28, 2021 Category: Drugs & Pharmacology Authors: admin Tags: COVID-19 vaccines Source Type: research
Drugs for Chronic Heart Failure
Date: June 14, 2021
Issue #:
1626Summary:
Among patients with chronic heart failure, those with
a left ventricular ejection fraction (LVEF)≤40% are
considered to have heart failure with reduced ejection
fraction (HFrEF). Patients with a LVEF≥50% are
considered to have heart failure with preserved ejection
fraction (HFpEF). Those with a LVEF of 41-49% are an
intermediate group more similar to patients with HFpEF. (Source: The Medical Letter)
Source: The Medical Letter - April 21, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Accupril ACE inhibitors Aldactone Altace ARBs Atacand Beta blockers BiDil Bisoprolol Bumetanide Burinex Candesartan Captopril Carvedilol cilazapril Coreg Corlanor Coversyl Cozaar dapagliflozin Digoxin Diovan Diu Source Type: research
MenQuadfi - A New Meningococcal (A, C, W, and Y) Vaccine
Date: May 17, 2021
Issue #:
1624Summary:
The FDA has licensedMenQuadfi (Sanofi Pasteur),
a quadrivalent polysaccharide conjugate vaccine
that uses tetanus toxoid as a protein carrier, for
prevention of invasive meningococcal disease caused
by Neisseria meningitidis serogroups A, C, W, and Y
(MenACWY) in persons≥2 years old. (Source: The Medical Letter)
Source: The Medical Letter - April 21, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Bexsero Menactra Meningococcal vaccine MenQuadfi Menveo Neisseria meningitidis Nimenrix Trumenba Source Type: research
Loteprednol 0.25% (Eysuvis) for Dry Eye Disease
Date: May 17, 2021
Issue #:
1624Summary:
The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis– Kala) for
short-term treatment (≤2 weeks) of dry eye disease.
It is the first ocular corticosteroid to be approved for
this indication. Other formulations of loteprednol are
approved for treatment of steroid-responsive ocular
inflammatory conditions, inflammation after ocular
surgery, and seasonal allergic conjunctivitis. (Source: The Medical Letter)
Source: The Medical Letter - April 21, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Alrex Cequa Cyclosporine Dry eye disease Eysuvis Inveltys Lacrisert lifitegrast Lotemax loteprednol Restasis Tobramycin Xiidra Zylet Source Type: research
Antibacterial Drugs for Lyme Disease
Date: May 17, 2021
Issue #:
1624Summary:
Lyme disease in the US is caused by the spirocheteBorrelia burgdorferi, which is transmitted to humans
byIxodes scapularis (blacklegged [deer] tick) andI. pacificus (western blacklegged tick). Most cases of
Lyme disease occur in late spring and early summer
in northeastern and mid-Atlantic states, the upper
Midwest, and in northern California.B. mayonii, which
is also transmitted byI. scapularis, has been shown to
cause a similar illness in the upper Midwest. (Source: The Medical Letter)
Source: The Medical Letter - April 21, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Amoxicillin Antibacterials Ceftriaxone Cefuroxime Doxycycline Insect repellents Lyme disease penicillin Source Type: research
Plenity for Weight Management
Date: May 17, 2021
Issue #:
1624Summary: Plenity (Gelesis), a nonsystemic oral superabsorbent
hydrogel formulation of cellulose and citric acid is
now available. It was cleared by the FDA in 2019 to
aid in weight management together with diet and
exercise in overweight and obese adults (BMI of
25-40 kg/m2). It is classified by the FDA as a device
because the contents of the capsule are not absorbed
systemically.Plenity is the first ingested, transient,
space-occupying hydrogel to be marketed in the US
and the only weight management treatment available
by prescription for patients with a BMI...
Source: The Medical Letter - April 15, 2021 Category: Drugs & Pharmacology Authors: admin Tags: alli Orlistat Plenity Weight loss Xenical Source Type: research
In Brief: New Recommendations for Gonococcal Infection
Date: May 3, 2021
Issue #:
1623Summary:
The CDC has issued new recommendations for
treatment of gonococcal infection. A single 500-mg
IM dose (1000 mg in patients weighing ≥150 kg) of the
third-generation cephalosporin ceftriaxone is now the
treatment of choice for patients with uncomplicated
urogenital, rectal, or pharyngeal gonorrhea. (Source: The Medical Letter)
Source: The Medical Letter - April 15, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
