- Ritedose Corporation received U.S. FDA approval to manufacture and distribute Tobramycin Inhalation Solution for patients aged six and older with Pseudomonas aeruginosa infections.
- The approval expands Ritedose’s nebulized drug portfolio, which the company says is now the largest in the United States.
The Ritedose Corporation (Ritedose) announced that the U.S. Food and Drug Administration (FDA) has approved the company’s manufacturing and distribution of Tobramycin Inhalation Solution. The antibiotic is indicated for treating Pseudomonas aeruginosa infections in patients aged six years and older, a common bacterial complication among individuals with cystic fibrosis.
The product will be marketed through Ritedose Pharmaceuticals, the company’s generics division and the largest sterile contract development and manufacturing organization (CDMO) in the U.S. Ritedose licensed the Abbreviated New Drug Application (ANDA) for Tobramycin from Hikma Pharmaceuticals.
“With the addition of Tobramycin, Ritedose now provides the largest nebulized drug portfolio in the country. Our recent investments in expanded facilities, cold chain processes and an additional packaging line have given us unparalleled capabilities in sterile manufacturing.”
Jody Chastain, CEO of Ritedose
The preservative-free Tobramycin Inhalation Solution is packaged as 300 mg doses in 5 ml ampules and administered through a nebulizer device. It is now available for purchase. The company emphasised that producing the drug domestically enhances supply chain resilience and access to critical therapies for patients with serious bacterial infections.
Tobramycin marks Ritedose’s third FDA-approved generic drug this year, following approvals for Formoterol Fumarate Inhalation Solution in April and Albuterol Sulfate Inhalation Solution in March.
