Cipla gets final approval from USFDA for Albuterol Sulfate Inhalation Aerosol

NEW DELHI: Cipla Ltd on Thursday said it has received final approval from the US health regulator for Albuterol Sulfate Inhalation Aerosol used in the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

In a regulatory filing the company said “it 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 (US FDA).”

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

Vohra further said that the company is planning shipments in a staggered manner.

“We are also ensuring that we do our bit by donating the product in this time of need,” Vohra added.

Cipla’s Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, is the firstAB-rated generic therapeutic equivalent version of Merck Sharp & DohmeCorp’s Proventil HFA Inhalation Aerosol.