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 (Reverified 10/09/2018)

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) Available 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) Limit availability / Recovery expected Q4 Manufacturer interruption production issues. 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

Aurobindo Pharma (New 09/28/2018)

Company Contact Information:
866-850-2876

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dorzolamide HCl and Timolol Maleate (Cosopt® PF) Ophthalmic Solution 2%/0.5% Preservative Free, 2mL single use container (NDC 65862-0947-60) Available Available Other

Sandoz (Reverified 11/06/2018)

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) Limited supply in-house. On allocation due to continued high demand Marketed by Sandoz Inc. To order, contact Sandoz Inc. at 1-800-525-8747 Demand increase for the product

Teva Pharmaceuticals (Reverified 11/09/2018)

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) Unavailable This was a business-related decision to discontinue manufacturing these products.

Link to Discontinuance

Discontinuation of the manufacture of the drug

Valeant Pharmaceuticals North America LLC (Reverified 10/05/2018)

Company Contact Information:
800-321-4576

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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