快樂小藥師
目前分類:FDA 公告 (120)
- Mar 26 Tue 2019 23:14
FDA approves Zulresso as first treatment for post-partum depression
- Sep 02 Sun 2018 06:05
[FDA Approvals] FDA Approves Pifeltro and Delstrigo for HIV
The US Food and Drug Administration (FDA) has approved two new oral treatments for adults with HIV-1 infection, Pifeltro and Delstrigo, both from Merck & Co, according to a company news release.
- Aug 28 Tue 2018 11:30
[FDA Approvals] FDA Clears First Tretinoin Lotion for Acne (Altreno)
- Jun 29 Fri 2018 06:00
[FDA] FDA Approves Plazomicin (Zemdri) for Urinary Tract Infections
Achaogen Inc said on Tuesday U.S. health regulators cleared its antibiotic Zemdri (plazomicin) to treat adults with complicated urinary tract infections, but declined approval for treating bloodstream infections.
- Jun 06 Wed 2018 09:00
[FDA]FDA Approves First Nonopioid Drug Lucemyra for Opioid Withdrawal
- Jun 05 Tue 2018 09:00
[FDA]FDA Approves Lokelma for Hyperkalemia
The US Food and Drug Administration (FDA) has approved sodium zirconium cyclosilicate (Lokelma, AstraZeneca) — a medication that rapidly restores normal potassium levels — for adults with hyperkalemia.
- Jun 03 Sun 2018 09:00
[FDA]FDA OKs Asthma Inhaler Arnuity Ellipta for Kids as Young as 5 Years
The US Food and Drug Administration (FDA) has expanded the use of the inhaled corticosteroid fluticasone furoate (Arnuity Ellipta, GlaxoSmithKline) as a once-daily asthma maintenance treatment for children as young as age 5 years.
- Jun 02 Sat 2018 09:11
[FDA]FDA Approves Imvexxy for Moderate to Severe Dyspareunia
The US Food and Drug Administration (FDA) has approved estradiol vaginal inserts (Imvexxy, TherapeuticsMD) for women with moderate to severe dyspareunia (vaginal pain during sex) resulting from menopause.
- Feb 23 Fri 2018 21:03
[FDA Alert]Clarithromycin Risky in Patients With Heart Disease
Healthcare providers should exercise caution when prescribing the macrolide antibiotic clarithromycin (Biaxin, generics) to patients with coronary heart disease because of a potential increased risk for heart problems or death that can occur years later, the US Food and Drug Administration (FDA) said today in a safety communication.
- Nov 10 Fri 2017 15:30
[FDA Approval]Prevymis™ (letermovir) for Prevention of Cytomegalovirus (CMV) Infection
Merck Receives FDA Approval of PREVYMIS™ (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients
- May 11 Thu 2017 11:00
FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
美國食品藥品管理局(FDA)發布安全性警示公告稱,一項安全性臨床試驗的初步結果表明,與別嘌醇相比,抗痛風藥非布司他(febuxostat,商品名Uloric)可能增加心臟相關性死亡的風險。
- Sep 16 Wed 2015 06:51
FDA Proposes Withdrawal of Low Blood Pressure Drug
- Jun 30 Tue 2015 07:30
FDA Alert – Daytrana (Methylphenidate Transdermal) Linked to Permanent Skin Discoloration
Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes
- Apr 01 Wed 2015 20:44
[FDA Approvals]FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
- Dec 21 Sun 2014 00:06
FDA approves new antibacterial drug Zerbaxa(ceftolozane/tazobactam)
The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
- Feb 10 Mon 2014 05:42
Acetaminophen, Opioids, and Safety
- Jan 23 Thu 2014 07:25
How is a medicine approved by FDA? FDA如何核准藥物的?
- Jan 18 Sat 2014 07:19
FDA approves first drug treatment for Peyronie’s disease
The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.
- Dec 06 Fri 2013 05:16
[FDA Approvals]FDA Approves Macitentan for PAH
The US Food and Drug Administration (FDA) has approved macitentan (Opsumit, Actelion) to treat pulmonary arterial hypertension (PAH) in adults[1].
- Dec 05 Thu 2013 04:08
[FDA Approvals]FDA Approves MitraClip for Degenerative MR