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 04/06/2018)

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) Currently Unavailable: Additional limited quantities targeted for Mid-June 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: Will continue to release lots weekly until targeted Backorder Recovery of 3Q is achieved 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 (Reverified 04/18/2018)

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 backorders until April 2018. Labeled under Sandoz Inc. To order, contact Sandoz Inc. at 1-800-525-8747 Demand increase for the product

Valeant Pharmaceuticals North America LLC (Revised 04/06/2018)

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) Supply available 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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