Aurobindo gets FDA approval for tobramycin inhalation stolution

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. 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 are 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.


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