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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Dexamethasone, Tobramycin Suspension/ Drops
Status: Discontinuation
»Therapeutic Categories: Ophthalmology

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Novartis Pharmaceuticals Corporation (New 06/26/2023)

Company Contact Information:
888-669-6682

Presentation Posting Date Related Information
Tobradex, Suspension/ Drops, 1 mg/1 mL; 3 mg/1 mL (NDC 0078-0953-40) 06/26/2023 Novartis Pharmaceuticals has made a business decision to permanently discontinue TOBRADEX® (tobramycin and dexamethasone ophthalmic suspension) Sterile suspension. Discontinuation of the product is not due to manufacturing, product quality, safety, or efficacy concerns. Product will be available until approximately September 2023. The authorized generic, 2.5 mL NDC 61314-647-25, 5 mL NDC 61314-647-05 and 10 mL NDC 61314-647-10 will continue to be manufactured and available, distributed by Sandoz. Other generic equivalents are also available.
Tobradex, Suspension/ Drops, 1 mg/1 mL; 3 mg/1 mL (NDC 0078-0953-25) 06/26/2023 Novartis Pharmaceuticals has made a business decision to permanently discontinue TOBRADEX® (tobramycin and dexamethasone ophthalmic suspension) Sterile suspension. Discontinuation of the product is not due to manufacturing, product quality, safety, or efficacy concerns. Product will be available until approximately September 2023. The authorized generic, 2.5 mL NDC 61314-647-25, 5 mL NDC 61314-647-05 and 10 mL NDC 61314-647-10 will continue to be manufactured and available, distributed by Sandoz. Other generic equivalents are also available.
Tobradex, Suspension/ Drops, 1 mg/1 mL; 3 mg/1 mL (NDC 0078-0953-26) 06/26/2023 Novartis Pharmaceuticals has made a business decision to permanently discontinue TOBRADEX® (tobramycin and dexamethasone ophthalmic suspension) Sterile suspension. Discontinuation of the product is not due to manufacturing, product quality, safety, or efficacy concerns. Product will be available until approximately September 2023. The authorized generic, 2.5 mL NDC 61314-647-25, 5 mL NDC 61314-647-05 and 10 mL NDC 61314-647-10 will continue to be manufactured and available, distributed by Sandoz. Other generic equivalents are also available.
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