VPRIV (velaglucerase alfa for injection) has received FDA approval and is now available from Shire Human Genetic Therapies, Inc. For additional information please contact Shire at: ONEPATH , or by phone at 1-866-888-0660.
Hospira will have a delivery of Ephedrine available in mid March. Hospira will have not have additional deliveries until May, at which time we will resume regular deliveries. (NDC 00409-3073-31)
Parenta is releasing product as it becomes available and estimate that the backorder will be resolved mid-March 2010. (NDC 66758-0008-02)
Akorn has product available and continues to release. (NDC 17478-0515-00)
Epinephrine 0.1 mg/mL Emergency Syringes 10 mL LifeShield Abboject syringe with 1.5 inch, 21-gauge needle (NDC 00409-4921-34)
Unanticipated increased demand
Hospira is working to increase production to respond to the increased demand and plans to have releases by end of June with additional releases in July and beyond.
Please see the American Society of Health Systems Pharmacists link below for important safety information regarding the use of alternate epinephrine injectables during the shortage: Epinephrine 0.1 mg/mL Emergency Syringes
Guerbet has acquired the Ethiodol NDA from Nycomed US Inc. effective May 7, 2010 and is working with FDA to resume manufacturing of Ethiodol in the near future to ensure continued availability for the US patients. During this interim period, Guerbet, in conjunction with the FDA, is initiating a temporary importation of LIPIODOL ULTRA-FLUIDE, ethyl esters of iodized fatty acids of poppy seed oil, to the United States market. See Dear Healthcare Professional Letter (PDF - 325KB) for additional information. (Letter updated 6/10/2010)
Hospira is allocating all the presentations to help manage the backorder situation and is working to restore adequate supply.
Product on backorder. American Regent, Inc., the distributor of Furosemide Injection, USP 10 mg/mL manufactured by Luitpold Pharmaceuticals, Inc., has and will continue to notify its wholesalers of the product release dates for all three presentations of Furosemide Injection, USP 10 mg/mL (2 mL vial, 4 mL in a 5 mL vial and 10 mL vial) so they can communicate product availability and appropriately allocate to the end user.
APP is increasing production to meet market demands. Currently, APP is allocating furosemide 10 mg/mL in 2ml injection (NDC 63323-0280-02) for emergencies only and anticipate additional batch releases mid July. APP is currently back-ordered on furosemide 10 mg/mL in 4ml injection (NDC 63323-0280-04) vials and anticipating multiple batch releases the week of June 28.
Bedford Laboratories Customer Service
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Teva has all presentation on back order with an estimated release date of November of 2010.
Ortho-McNeil has Haldol Decanoate available in 50 mg/mL 1 mL ampoules in 3 count (NDC 00045-0253-03) presentations and 100 mg/mL 1 mL ampoules (NDC 00045-0254-14).
APP has haloperidol decanoate available in 50 mg/mL 1 mL vials (NDC 63323-0469-01), 50 mg/mL 5 mL vials (NDC 63323-0469-05), 100 mg/mL 1mL vials (NDC 63323-0471-01), and 100 mg/mL 5 mL vials (NDC 63323-0471-05). The dating on the haloperidol decanoate 50 mg/mL 1 mL is 8 months. Additional batches of 100 mg/mL 1mL and 50 mg/mL 5 mL will be available late-June.
Bedford has on allocation haloperidol decanoate 50 mg/mL 1 mL vials (NDC 55390-0412-01). All other presenations are on back order and expected to be available in the next 1-2 months.
Heparin Sodium Large Volume Premixed Infusion Solutions
Shortage of Heparin Sodium drug substance that meets current qualification requirements
Shortage of finished product that meets current specification.
Short supply of drug substance and unanticipated issues to implement the new USP Heparin monograph.
B. Braun is working to resolve the issues that have led to the shortage. B. Braun estimates that the back-order will be resolved by mid-June, and has all large volume heparin infusion solutions available on allocation.
Baxter is working to resolve the issues that have led to the shortage but there is not yet a timeline reported for availability. Baxter continues to have available their heparin sodium 1000u/500 ml in 0.9% Sodium Chloride and heparin sodium 2000u/1000ml in 0.9% Sodium Chloride. Please see Dear Valued Baxter Customer Letter (PDF - 87KB)
Hospira has all large volume heparin infusion solutions available on allocation.
Please also note that APP continues to have all high dose heparin sodium injectable vials available including those vials suitable for compounding large volume infusion solutions; heparin sodium 50,000U/10mL NDC# 63323-0047-10 and heparin sodium 50,000U/5mL NDC# 63323-0542-07 vials. For additional product questions please call APP Customer Service at 1-888-386-1300
Product continues to be available with short expiration dating.
Sandoz has continued to make isoniazid injection available and the product may be ordered through wholesalers.
Leucovorin Calcium Lyophilized Powder for Injection
Bedford has available leucovorin calcium lyophilized powder for injection 50 mg (NDC 55390-0051-10) and 200 mg (NDC 55390-0053-01) vials. All other presentations are on back order with estimated release dates in July and August, 2010.
Teva has all presentations on back order with an estimated release date the week of June 28, 2010.
Customer service number:
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Contractor will no longer pursue commercial manufacturing. Lundbeck is working to transfer to a new manufacturing site.
Currently a limited amount of Mustargen is available with a September 2010 expiration date and this will be distributed by Lundbeck to meet patient needs (pharmacies will need to call their wholesaler to obtain quantities of Mustargen to meet patient needs.
Once the limited supply runs out there is anticipated to be a shortage until product is available from a new manufacturing site and FDA is working closely with Lundbeck to make this happen as soon as possible.
Current projections from Lundbeck are that new Mustargen product may not be available until end of 2010 but we are continuing to work with Lundbeck and updates will be provided as they become available.
Amphastar-IMS has available naloxone 1 mg/mL 2 mL syringes with needles (NDC 0548-1469-00) or without needles (NDC 0548-3369-00).
Hospira has all naloxone 0.4 mg/mL presentations on back order, however, the company expects to clear all backorders by late June, 2010, with full recovery (reach target inventory position) by end of July, 2010.
FDA has requested that UCB reformulate Neupro (rotigotine transdermal system) patches. UCB is committed to bringing Neupro to U.S. patients and has already made significant progress in the development of the new formulation.
If you have additional questions about the status of Neupro, or about UCB’s Patient Access program for Neupro, please contact UCB Medical Information at 1-866-822-0068 (option 9).
Unexpected Increased Demand and Manufacturing Delays
Abbott expects sporadic inventory availability through June 2010. Abbott advises that due to increased demand for Nimbex (cisatracurium), it is advisable to place orders at your wholesaler before the expected delivery dates to improve likelihood of inventory procurement.
Valeant Pharmaceuticals International
Valeant has released limited quantity of Oxsoralen-Ultra 10mg capsules to the market and is committed to ensuring the product is allocated properly to patients in need. Please see the Dear Healthcare Professional Letter (PDF - 49KB) for additional information.
Teva Pharmaceuticals has discontinued their propofol injection.
Hospira Inc. recalled specific lots because some containers may contain particulate matter. Hospira has implemented improvements to its manufacturing process and is coordinating with the FDA to begin distribution of propofol manufactured under a new process as soon as possible.
APP has increased production in response to the increased demand. Please see additional information on availability in the Related Information section