FDA approves generic of Proventil HFA (albuterol sulfate) Me
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
Get authentic, real-time news that helps you fight COVID-19 better.
Install PlexusMD App for doctors. It's free.
The U.S. Food and Drug Administration approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.

“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, M.D. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”

The most common side effects associated with Albuterol Sulfate Metered Dose Inhaler, 90 mcg/Inhalation, are upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate (tachycardia), tremor and nervousness.

The FDA regularly takes steps to help guide industry through the development process for generic products, including complex combination products, such as metered-dose inhalers, that consist of a drug and a device. The development of many generic combination products can be more challenging than solid oral dosage forms, like tablets.

Under the Generic Drug User Fee Amendments (GDUFA), individual companies can meet with the FDA as part of its pre-Abbreviated New Drug Application (ANDA) program to support the development of such complex generic drug products. The FDA also publishes guidance documents describing the steps the FDA recommends companies take to submit complete applications for generic drug products.

The FDA granted approval of this generic albuterol sulfate inhalation aerosol to Cipla Limited.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm
Dr. T●●●●z H●●●●●●i and 17 others like this7 shares
Like
Comment
Share
Dr. D●●●●k G●●e
Dr. D●●●●k G●●e Internal Medicine
Good news,good drug
Apr 9, 2020Like1
M●●●●h N●●●k
M●●●●h N●●●k Ayurvedic Medicine
Good news our India
Apr 9, 2020Like