FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Levetiracetam Extended-Release Oral Tablets, USP
Status: Currently in Shortage
»Date first posted: 05/28/2019
»Therapeutic Categories: Neurology

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Apotex Corp. (Revised 11/27/2019)

Company Contact Information:
800-706-5575

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Levetiracetam Extended-Release Tablets 500 mg (60 ct. bottle)(NDC 60505-3280-06) Backorder, Estimated Resupply February 2020 Demand increase for the drug
Levetiracetam Extended-Release Tablets 750 mg (60 ct. bottle)(NDC 60505-3517-06) Backorder, Estimated Resupply February 2020 Demand increase for the drug

Lupin (Reverified 12/05/2019)

Company Contact Information:
866-587-4617

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
500mg 60 count bottle (NDC 68180-117-07) Continuous production but will be on/off backorder Shortage of active ingredient
750mg 60 count bottle (NDC 68180-118-07) Continuous production but will be on/off backorder Shortage of active ingredient

Solco Healthcare US, LLC (New 05/28/2019)

Company Contact Information:
866-931-9829

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Levetiracetam ER Tablets, 500mg, 60’s (NDC 43547-0345-06) Long-term backorder for all skus. No estimated release date at this time.
Levetiracetam ER Tablets, 500mg, 500’s (NDC 43547-0345-50) Long-term backorder for all skus. No estimated release date at this time.
Levetiracetam ER Tablets, 750mg, 60’s (NDC 43547-0346-06) Long-term backorder for all skus. No estimated release date at this time.
Levetiracetam ER Tablets, 750mg, 500’s (NDC 43547-0346-50) Long-term backorder for all skus. No estimated release date at this time.

Sun Pharmaceutical Industries Inc. (Revised 12/03/2019)

Company Contact Information:
800-818-4555

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
500mg tablet 60 count bottle (NDC 4733557386) Back-order, Estimated re-supply: TBD Demand increase for the drug
750mg tablet 60 count bottle (NDC 4733557686) Back-order, Estimated re-supply: TBD Demand increase for the drug

UCB Inc. (Reverified 12/03/2019)

Company Contact Information:
919-767-3210

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
500mg extended-release (NDC 50474-598-66) Available
750mg extended-release (NDC 50474-599-66) Available

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