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Three New Drugs for Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • May 23, 2016 (Issue 1495)
approval
for use in patients with relapsed or refractory multiple
myeloma (1-3 prior therapies), targets ...
The FDA recently approved ixazomib (Ninlaro –
Takeda), daratumumab (Darzalex – Janssen Biotech),
and elotuzumab (Empliciti – BMS) for treatment of
relapsed and/or refractory multiple myeloma.
QuilliChew ER - Extended-Release Chewable Methylphenidate Tablets
The Medical Letter on Drugs and Therapeutics • May 23, 2016 (Issue 1495)
chewable
methylphenidate tablets (Methylin, and generics) have
been available since 2003.1 ...
The FDA has approved a once-daily, extended-release
chewable tablet formulation of methylphenidate
(QuilliChew ER – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first
long-acting chewable formulation of the drug to be
marketed in the US. Immediate-release chewable
methylphenidate tablets (Methylin, and generics) have
been available since 2003.
Ciprofloxacin (Otiprio) for Tympanostomy Tube Insertion
The Medical Letter on Drugs and Therapeutics • May 23, 2016 (Issue 1495)
to 12 years old is tympanostomy tube insertion
(TTI).1 About 667,000 TTIs are performed annually ...
The FDA has approved ciprofloxacin 6% otic
suspension (Otiprio – Otonomy) for single-dose
prophylaxis in children with bilateral otitis media
with effusion who are undergoing tympanostomy
tube placement. It is the first drug to be approved
for this indication in the US. Otic formulations
of the fluoroquinolone antibiotics ofloxacin
(Floxin Otic, and generics) and ciprofloxacin (plus
dexamethasone; Ciprodex) have been available for
years for treatment of acute otitis media in children
with tympanostomy tubes; an otic suspension
containing ciprofloxacin and fluocinolone...
Ixekizumab (Taltz) - A Second IL-17A Inhibitor for Psoriasis
The Medical Letter on Drugs and Therapeutics • May 09, 2016 (Issue 1494)
antagonist to be approved for this indication in the US;
secukinumab (Cosentyx – Novartis) was the first.1 ...
The FDA has approved ixekizumab (Taltz – Lilly), an
injectable humanized interleukin (IL)-17A antagonist,
for treatment of adults with moderate to severe plaque
psoriasis who are candidates for systemic therapy
or phototherapy. Ixekizumab is the second IL-17A
antagonist to be approved for this indication in the US;
secukinumab (Cosentyx – Novartis) was the first.
BioThrax and Anthrasil for Anthrax
The Medical Letter on Drugs and Therapeutics • May 09, 2016 (Issue 1494)
such
as ciprofloxacin or doxycycline.1,2 Raxibacumab, an
intravenous human monoclonal antibody available
only ...
The FDA has approved anthrax vaccine adsorbed (AVA;
BioThrax – Emergent BioSolutions) for prevention of
anthrax disease in adults following exposure to Bacillus
anthracis and intravenous anthrax immune globulin
(Anthrasil – Emergent BioSolutions) for treatment of
inhalation anthrax in adults and children. AVA has been
available since 1970 for prevention of anthrax disease
in persons at high risk of exposure.
Odefsey - Another NNRTI Combination for HIV
The Medical Letter on Drugs and Therapeutics • May 09, 2016 (Issue 1494)
transcriptase
inhibitors (NRTIs) emtricitabine and tenofovir
alafenamide, for initial treatment of HIV-1 ...
The FDA has approved Odefsey (Gilead), a once-daily,
fixed-dose combination of the non-nucleoside
reverse transcriptase inhibitor (NNRTI) rilpivirine
and the nucleoside/nucleotide reverse transcriptase
inhibitors (NRTIs) emtricitabine and tenofovir
alafenamide, for initial treatment of HIV-1 infection in
patients with HIV-1 RNA (viral load) ≤100,000 copies/mL or to replace a stable antiretroviral regimen in
patients who have been virologically suppressed
(viral load <50 copies/mL) for at least six months with
no history of treatment failure.
In Brief: Two Drugs for Soft-Tissue Sarcoma (online only)
The Medical Letter on Drugs and Therapeutics • May 09, 2016 (Issue 1494)
(Halaven – Eisai), which was approved earlier for treatment
of metastatic breast cancer,1 for treatment ...
The anthracycline doxorubicin with or without the alkylating agent ifosfamide is the standard first-line treatment for advanced soft-tissue sarcomas. The FDA recently approved the minor groove DNA intercalator trabectedin (Yondelis – Janssen) for treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients previously treated with an anthracycline. Trabectedin has been available for years in Europe for treatment of advanced soft-tissue sarcoma. The FDA has also approved the microtubule inhibitor eribulin mesylate (Halaven – Eisai), which was approved earlier for...
Cariprazine (Vraylar) for Schizophrenia and Bipolar I Disorder
The Medical Letter on Drugs and Therapeutics • Apr 25, 2016 (Issue 1493)
Table 1. Pharmacology
Class Second-generation antipsychotic
Mechanism Dopamine (D2) and serotonin (5 ...
The FDA has approved cariprazine (Vraylar – Actavis), an
oral, once-daily, second-generation antipsychotic, for treatment
of schizophrenia and for acute treatment of manic or
mixed episodes associated with bipolar I disorder.
Mifepristone (Mifeprex) Label Changes
The Medical Letter on Drugs and Therapeutics • Apr 25, 2016 (Issue 1493)
of intrauterine pregnancy.1 It
has generally been used with the prostaglandin analog
misoprostol (Cytotec ...
The FDA has approved several significant changes in
the labeling of mifepristone (Mifeprex – Danco), an oral
antiprogestin that has been used in the US for more than
15 years for termination of intrauterine pregnancy. It
has generally been used with the prostaglandin analog
misoprostol (Cytotec, and generics).
Maestro Rechargeable System for Weight Loss
The Medical Letter on Drugs and Therapeutics • Apr 25, 2016 (Issue 1493)
procedures such as adjustable gastric
banding or sleeve gastrectomy.1 Gastric balloon devices
are inserted ...
The FDA has approved the Maestro Rechargeable
System (EnteroMedics), a subcutaneously implanted
device, for use in adults who have not been able to lose
weight with a weight loss program within the past 5 years
and who have a body mass index (BMI) of 40 to 45, or a
BMI ≥35 and at least one obesity-related comorbidity.