Aurobindo Announces FDA Approval of Tobramycin Inhalation Solution

Aurobindo Pharma’s Tobramycin Inhalation Solution is an AB-rated generic equivalent to the reference Tobi Inhalation Solution.

Aurobindo Pharma Limited has received final approval from US Food and Drug Administration for its Abbreviated New Drug Application Tobramycin Inhalation Solution, 300 mg/5 mL. Aurobindo Pharma’s Tobramycin Inhalation Solution, 300 mg/5 mL is an AB-rated generic equivalent to the reference listed drug (RLD), Tobi® Inhalation Solution, 300 mg/5 mL marketed by Novartis.

Tobramycin Inhalation Solution is indicated for:

  • Management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa.

SOURCE: Aurobindo Pharma