Aurobindo Pharma Wins FDA Approval for First Metered-Dose Inhaler, Generic Beclomethasone Aerosol
核心洞察
Aurobindo Pharma received final FDA approval for Beclomethasone Dipropionate HFA Inhalation Aerosol (搜索) 40 mcg and 80 mcg, its first metered-dose inhaler product.
The product is a generic equivalent of Teva's QVAR Inhalation Aerosol (搜索) and is indicated for maintenance treatment of asthma (搜索) as prophylactic therapy.
Manufacturing will take place at Aurolife Pharma's Raleigh, North Carolina facility, with launch expected in upcoming quarters.
Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (搜索) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol (搜索), 40 mcg and 80 mcg, marking the company's first metered-dose inhaler (MDI) product and its entry into the complex respiratory therapies and inhalation segment.
The product is a generic equivalent of QVAR Inhalation Aerosol (搜索), 40 mcg and 80 mcg, marketed by Teva Branded Pharmaceutical Products R&D LLC (搜索). According to the company, the approval represents a milestone in its expansion into complex respiratory therapies.
Indication and Clinical Role
Beclomethasone Dipropionate HFA Inhalation Aerosol (搜索) is indicated for the maintenance treatment of asthma (搜索) as prophylactic therapy in patients aged 5 years and older. It is also indicated for asthma patients who require systemic corticosteroid administration, where adding Beclomethasone Dipropionate HFA Inhalation Aerosol may reduce or eliminate the need for systemic corticosteroids.
Manufacturing and Launch Timeline
The product will be manufactured at Aurobindo Pharma's Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary, Aurolife Pharma LLC. The company expects to launch the product in the upcoming quarters.
Market Size and Portfolio Expansion
Citing IQVIA data, Aurobindo said the U.S. market for the approved product and newer versions of the reference product, QVAR RediHaler, was estimated at US$301 million for the 12 months ended July 2026.
"Building on our leadership in Generics, we are now expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market," the company said.
With the latest approval, Aurobindo Pharma's cumulative USFDA ANDA approvals stand at 596, comprising 571 final approvals and 25 tentative approvals, further expanding its portfolio of complex and differentiated products.
Company Profile
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures and commercializes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in more than 150 countries.
The company has more than 30 manufacturing and packaging facilities approved by leading regulatory agencies, including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC and Brazil ANVISA. Its product portfolio covers seven major therapeutic/product areas, including CNS, anti-retroviral, CVS, antibiotics, gastroenterology, anti-diabetics and anti-allergics, supported by its R&D operations.