USFDA grants final approval to Cipla's Albuterol Sulfate Inhalation Aerosol
11 April 2020 -

United States Food and Drug Administration (USFDA) has granted final approval to Cipla Limited (BSE: 500087) (NSE: CIPLA EQ), a global pharmaceutical company, over its Abbreviated New Drug Application for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, it was reported on Thursday, 9 April.

The product is the first AB-rated generic therapeutic equivalent version of Merck Sharp & Dohme Corp's Proventil HFA Inhalation Aerosol. It is to treat acute bronchospasm and for prevention of asthmatic symptoms.

Umang Vohra, MD and Global CEO, Cipla Limited, 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. 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. We are planning shipments in a staggered manner. We are also ensuring that we do our bit by donating the product in this time of need.'