Cipla gets USFDA nod for generic inhaler

Pharma major Cipla on Thursday said it has received final nod from the US health regulator for generic Albuterol Sulfate inhalation aerosol used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

The company has received final approval for its abbreviated new drug application (ANDA) for Albuterol Sulfate inhalation aerosol 90mcg (base)/actuation, from the United States Food and Drug Administration (USFDA), Cipla said in a statement.

The company's product is the first generic version of Merck Sharp & Dohme Corp's Proventil HFA inhalation aerosol, it added.

According to IQVIA (IMS Health) data, Proventil HFA inhalation aerosol and its authorised generic equivalent had US sales of about USD 153 million for the 12-month period ending February 2020, it added.

The entire Albuterol Sulfate HFA inhalation aerosol market had US sales of nearly USD 2.8 billion for the 12-month period ending February 2020, Cipla said.

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

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, he added.

"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 said.

Cipla is planning shipments in a staggered manner.

The company is also ensuring that it does its bit by donating the product in this time of need, the statement said.

The product is used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, Cipla said.

Shares of Cipla were on Thursday trading at Rs 582.35 per scrip on the BSE, up 13.52 per cent from its previous close.