Cipla gets USFDA nod for asthma inhalation drug Albuterol Sulfate aerosol

The entire Albuterol Sulfate HFA Inhalation Aerosol market had US sales of approximately $2.8 billion for the 12-month period ending February 2020.

Moneycontrol News

April 09, 2020 / 09:26 IST

26 Aug, 2025 12:21

Volume

Todays L/H

Drug maker Cipla said on April 9 that it had received the final approval from USFDA for its for asthma medication Albuterol Sulfate Inhalation Aerosol 90mcg actuation.

Cipla’s Albuterol Sulfate Inhalation Aerosol 90mcg is the first AB-rated generic therapeutic equivalent version of Merck Sharp & Dohme Corp Proventil HFA Inhalation Aerosol. An AB-rated refers to generic drugs that met necessary bioequivalence requirements.

It is used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

According to IQVIA, Proventil HFA Inhalation Aerosol and its authorised generic equivalent had US sales of approximately $153 million for the 12-month period ending in February. The entire Albuterol Sulfate HFA Inhalation Aerosol market had US sales of approximately $2.8 billion for the 12-month period ending February 2020.

“We are pleased to receive the final approval for generic Albuterol MDI from the USFDA. This further strengthens our presence in the US market," said Umang Vohra, MD and Global CEO - Cipla.

COVID-19 Vaccine

Frequently Asked Questions

How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

Show