11/12/2024

Bivalirudin Injection

Products Affected - Description

- Bivalirudin lyophilized powder for injection, Eugia US, 250 mg, vial, 10 count, NDC 55150-0210-10
- Bivalirudin solution for injection, Par Pharmaceuticals, ready-to-use 250 mg/50 mL, vial, 10 count, NDC 42023-0622-10
- Bivalirudin lyophilized powder for injection, Pfizer, 250 mg, ADD-Vantage vial, 10 count, NDC 00409-8300-15 - discontinued
- Bivalirudin lyophilized powder for injection, Sagent, 250 mg, vial, 10 count, NDC 70860-0402-10
- Bivalirudin lyophilized powder for injection, Sandoz, 250 mg, vial, 10 count, NDC 00781-3158-95

Reason for the Shortage

- Eugia did not provide a reason for the shortage.
- Pfizer discontinued bivalirudin 250 mg ADD-Vantage vials in early-2024.
- Meitheal has bivalirudin injection available.
- Fresenius Kabi has bivalirudin injection available.
- Par (Endo) has bivalirudin ready-to-use vials on shortage due to increased demand.
- Sagent did not provide a reason for the shortage.
- Slate Run has bivalirudin injection available.
- Viatris has bivalirudin injection available.
- Sandoz did not provide a reason for the shortage.
- Dr. Reddy's availability information is forthcoming.
- Accord availability information is forthcoming.

Available Products

- Bivalirudin lyophilized powder for injection, Fresenius Kabi, 250 mg, vial, 10 count, NDC 63323-0562-10
- Bivalirudin lyophilized powder for injection, Meitheal Pharmaceuticals, 250 mg, vial, 10 count, NDC 71288-0427-11
- Bivalirudin lyophilized powder for injection, Mylan (Viatris), 250 mg, vial, 10 count, NDC 67457-0256-10
- Bivalirudin lyophilized powder for injection, Slate Run Pharmaceuticals, 250 mg, vial, 10 count, NDC 70436-0025-82

Estimated Resupply Dates

- Eugia has bivalirudin 250 mg vials on intermittent back order and the company is releasing supplies as they become available.
- Par (Endo) has bivalirudin 250 mg/50 mL ready-to-use vials on back order and the company estimates a release date of early-December 2024.
- Sagent has bivalirudin 250 mg vials available with short expiration dating (May 2025).
- Sandoz has bivalirudin 250 mg vials on intermittent back order and the company is releasing supplies as they become available.

Updated

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