Generic form of antibiotic for CF lung infections wins FDA approval
- Admin
- 4 days ago
- 2 min read
Tobramycin inhalation solution offers affordable option to patients 6 and older
The U.S. Food and Drug Administration (FDA) has approved a new generic form of inhaled tobramycin, an antibiotic that’s used to treat bacterial lung infections in people with cystic fibrosis (CF).
The newly approved therapy, tobramycin inhalation solution, will be sold by The Ritedose Corporation through its generics division, Ritedose Pharmaceuticals. It is indicated to treat Pseudomonas aeruginosa infections in CF patients ages 6 and older.
“With the addition of Tobramycin, Ritedose now provides the largest nebulized drug portfolio in the country,” Jody Chastain, CEO of Ritedose, said in a company press release. “Our recent investments in expanded facilities, cold chain processes, and an additional packaging line have given us unparalleled capabilities in sterile manufacturing.”
Lung infections a common health problem for CF patients
Generic medications are therapies that are chemically identical to name-brand medications. Generics are usually cheaper than their name-brand counterparts, and since they introduce more competition into the pharmaceuticals marketplace, they can often help drive down prices generally. Name-brand versions of inhaled tobramycin that are currently available in the U.S. include Tobi, Bethkis, and Kitabis Pak.
CF is a genetic disorder characterized by thick, sticky mucus that builds up in the lungs and other organs. In the lungs, this buildup of thick mucus creates a haven for infectious bacteria, and as a consequence, bacterial lung infections are a common health problem for CF patients. P. aeruginosa, a bacteria commonly found in the environment, is often a key player in CF lung infections. Currently, the standard-of-care treatment for these infections is antibiotics, medications that kill bacteria or prevent them from spreading.
Now with Tobramycin in our portfolio, we can provide affordable, safe, and reliable medications to patients with serious bacterial infections, expanding access to this critical therapy.
Tobramycin belongs to a class of antibiotics called aminoglycosides, which work to kill bacteria by blocking their ability to make new proteins.
Ritedose’s new generic is already available for purchase. The company obtained FDA approval for two other generics this year, one for chronic obstructive pulmonary disease, and the other for people with acute attacks of bronchospasms, when the muscles that line the airways in the lungs tighten, or reversible obstructive airway disease.
“Now with Tobramycin in our portfolio, we can provide affordable, safe and reliable medications to patients with serious bacterial infections, expanding access to this critical therapy,” Chastain said. “We’re also proud to strengthen supply chain resilience with the addition of a broad-spectrum antibiotic that is produced here in the United States.”
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