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.
Albuterol is the first generic metered dose inhaler of Proventil HFA Inhalation Aerosol ever approved by FDA in the US and Cipla’s first device-based inhalation product in the market.
"This development reiterates our commitment of strengthening our respiratory franchise and will further solidify our position as lung leader globally. We will continue to build on our portfolio of drug-device combinations in the respiratory space to serve the unmet needs of our patients across markets,” Vohra added.
Cipla said it was planning shipments in a staggered manner.
"We are also ensuring that we do our bit by donating the product in this time of need," the company added.
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