New Products

FDA Approves New Asthma Indication for Trelegy Ellipta

September 10, 2020

Fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta; GlaxoSmithKline) is indicated for the treatment of asthma in patients aged 18 years and older.

FDA OKs Tramadol Hydrochloride Oral Liquid for Pain Management

September 09, 2020

Tramadol hydrochloride (Qdolo; Athena Bioscience) oral solution is indicated for use when pain is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

FDA OKs Azacitidine Tablets for Acute Myeloid Leukemia

September 03, 2020

Oral azacitidine (Onureg; Celgene) is approved for patients in first remission with acute myeloid leukeimia.

Coronavirus News Roundup: FDA Issues EUA for Rapid Antigen Test, ASHP Releases COVID-19 Vaccine Guidelines

August 28, 2020

Here's the coronavirus-related news from this week that you should know.

FDA Issues Emergency Use Authorization to New 15-Minute COVID-19 Antigen Test

August 27, 2020

Abbott’s BinaxNOW COVID-19 Ag Card rapid test produces results in 15 minutes.

Amisulpride Injection Now Available in the US for Postoperative Nausea and Vomiting

August 25, 2020

Amisuplride injection (Barhemsys; Acacia) is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed prior prophylaxis with an agent of a different class.

Mylan Launches Generic Version of Multiple Sclerosis Treatment

August 20, 2020

Mylan has launched the first FDA-approved generic version of Biogen’s dimethyl fumarate (Tecfidera) for relapsing forms of multiple sclerosis.

FDA OKs Risdiplam for Treatment of Spinal Muscular Atrophy

August 07, 2020

Risdiplam (Evrysdi; Genentech) is the only SMA therapy that can be administered at home.

Stay in Sync with Innovations in Medication Decision Support

August 06, 2020

Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.

FDA OKs New Indication for Esketamine Nasal Spray

August 05, 2020

Esketamine (Spravato; Janssen) CIII nasal spray is the first FDA-approved antidepressant medication that improves depressive symptoms with the first dose in adults with major depressive disorder.

FDA Authorizes Use of Non-Invasive Nerve Stimulation Therapy for Asthma Exacerbations in COVID-19

July 15, 2020

The therapy will also be available for individuals with asthma and suspected COVID-19 infection.

CVS Pharmacy Offering New Spoken Rx App Feature

July 10, 2020

The new app feature will also soon function with smart labels, which can be scanned and read aloud.

Ready-to-Use Glucagon Injection for Severe Hypoglycemia Now Available

July 06, 2020

Xeris Pharmaceuticals’ new glucagon injection (Gvoke HypoPen), a ready-to-use glucagon formulation in a premixed autoinjector, is now available by prescription.

FDA Authorizes Third Combination Diagnostic Test for Flu and COVID-19

July 06, 2020

The FDA has granted emergency use authorization to an additional combination diagnostic test for influenza and COVID-19.

FDA Approves Fostemsavir for Heavily Pretreated Patients With HIV

July 03, 2020

Fostemsavir (Rukobia, ViiV Healthcare) is indicated for use in heavily treatment-experienced adults with multidrug resistant HIV-1 infection.

FDA Approves New Combo Breast Cancer Treatment for Subcutaneous Injection

July 01, 2020

The fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase (Phesgo; Genentech) can be administered subcutaneously for patients with HER2-positive breast cancer.

New Machine Learning Tool Can Predict Adverse Drug Effects

June 29, 2020

A new computer algorithm might be the next step toward accurate prediction of adverse drug reactions.

FDA OKs New Treatment for Seizures Associated with Dravet Syndrome

June 26, 2020

Officials with the FDA approved fenfluramine (Fintepla, Zogenix) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

FDA Approves Treatment for Recurrent Diabetes Gastroparesis

June 23, 2020

The first and only one of its kind, metoclopramide nasal spray offers relief to often debilitating symptoms of the gastrointestinal disease.

Barhemsys (Amisulpride) for Postoperative Nausea and Vomiting

June 22, 2020

On February 27, 2020, the FDA approved an intravenous solution of amisulpride (Barhemsys; Acacia Pharma) to treat and prevent postoperative nausea and vomiting.