FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution
Status: Currently in Shortage
»Date first posted: 01/24/2018
»Therapeutic Categories: Ophthalmology

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Akorn Pharmaceuticals (Revised 02/16/2018)

Company Contact Information:
800-932-5676

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Cosopt® dorzolamide hydrochloride 22.3 mg/mL and Timolol maleate 6.8 mg/mL, 10 mL (NDC 17478-605-10) Limited Supply Available: Late February / early March 2018. Targeted Backorder Recovery: 3Q due to supplier excipient. Manufacturer interruption due to supplier excipient. Marketed by Akorn, Inc. To order, contact Akorn Customer Service (1-800-932-5676) Other
Dorzolamide hydrochloride 22.3 mg/mL and Timolol maleate 6.8 mg/mL, 10 mL (NDC 50383-233-10) Limited Supply Available: Late February / early March 2018. Targeted Backorder Recovery: 3Q Manufacturer interruption due to supplier excipient. Marketed by Hi-Tech Pharmacal Co., Inc. To order, contact Akorn Customer Service (1-800-932-5676) Other
Cosopt-PF® dorzolamide hydrochloride 22.3 mg/mL and Timolol maleate 6.8 mg/mL, 0.2 mL single use, 60 count (NDC 17478-604-30) Available Marketed by Akorn, Inc. To order, contact Akorn Customer Service (1-800-932-5676) Other

Sandoz (Revised 02/21/2018)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dorzolamide hydrochloride 22.3 mg/mL and Timolol maleate 6.8 mg/mL, 10 mL (NDC 61314-030-02) Estimated intermittent back orders until March 2018. Labeled under Sandoz Inc. To order, contact Sandoz Inc. at 1-800-525-8747 Demand increase for the product

Teva Pharmaceuticals (New 01/24/2018)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dorzolamide hydrochloride 22.3 mg/mL and Timolol maleate 6.8 mg/mL, 10 mL (NDC 0591-2482-79) Product is unavailable and expected to be out of stock for a minimum of 4 months Supplier is working with FDA to address GMP issues concerning Quality systems. Marketed by Actavis Pharma, Inc. To order, contact: 1-800-545-8800 Requirements related to complying with good manufacturing practices

Valeant Pharmaceuticals North America LLC (New 01/24/2018)

Company Contact Information:
800-672-6372

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dorzolamide hydrochloride 22.3 mg/mL and Timolol maleate 6.8 mg/mL, 10 mL (NDC 24208-486-10) Limited supply available. Estimated recovery 3 weeks. Marketed by Bausch & Lomb Inc. To order, contact Bausch & Lomb, a division of Valeant Pharmaceuticals North America at pharcs@valeant.com Other

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