Drug Approval | April 23, 2026
Cipla’s generic Ventolin HFA secures USFDA approval
Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market
Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market
The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling
The system is powered by BrainSense technology, which has received approval from USFDA
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
OneSource is the contract development and manufacturing organization (CDMO) partner for this product
The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics
The study was conducted by PwC India in line with ISO 14040 and ISO 14044 protocols
The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation
The collaboration combines Takara Bio’s large-scale testing technology with Resistomap’s data-driven AMR intelligence
The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
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