March 22: Methotrexate Availability Update. Only Accord Healthcare is reporting that methotrexate is unavailable due to “complying with good manufacturing practices.” The four other manufacturers of the drug have some supply available, but methotrexate is still in shortage.
March 15: Cisplatin and Carboplatin Availability Update. Cisplatin manufacturers are all allocating at least the 1mg/1mL injections. Two carboplatin manufacturers are reporting backorder or unavailable supply, but around six manufacturers have at least some supply available. Supply is moving, but both cisplatin and carboplatin are still in shortage.
September 22, 2023: Cisplatin Availability Update. As of September 18, Quilu/Apotex has distributed all imported product and it is no longer available. Updates from other manufacturers include the following: Teva, allocating available supply; WG Critical Care, available on allocation; and Fresenius Kabi, on backorder with the next release in September 2023. Gland/Sagent has Cisplatin, Injection, 1 mg/1 mL (NDC 25021-253-50) on backorder with an estimated recovery in October 2023 and Cisplatin, Injection, 1 mg/1 mL (NDC 25021-253-51) is available and on allocation.
July 20, 2023: Carboplatin Availability Update. Ingenus Pharmaceuticals now has 450 mg/45mL (10 mg/mL) available. For more information contact the Ingenus team at 866-321-5031.
July 14, 2023: Cisplatin Availability Update: Apotex/Qilu has 10 additional batches of Cisplatin available for ordering. Please see the new Dear Healthcare Professional letter. Contact 800-706-5575 for more information. The FDA-approved manufacturer, Gland Pharma Limited, will have new supply starting the third week of July, from their distributor, Sagent. Contact 866-625-1618 for more information.
June 20, 2023: Carboplatin and Cisplatin Availability Update: Teva has a supply of 450 mg/45mL (10mg/mL) multi-dose vials of carboplatin. HQ Specialty Pharma is shipping 1 mg/mL (200mL) multi-dose vials of cisplatin to wholesalers and distributors this week.
June 2, 2023, Cisplatin Availability Update: The FDA has worked with Qilu Pharmaceuticals and Apotex Corp. to temporarily import cisplatin to help meet patient needs during the shortage. The FDA has assessed the product to ensure it is safe for US patients. See the prescribing information. The FDA will continue all efforts with the approved manufacturers in addition to any potential importation efforts to meet all patient needs.
May 24, 2023, Carboplatin Availability Update: Teva has a limited and available supply of the following for Carboplatin: 50 mg/5mL, 150mg/15mL, 450mg/45mL, and 600mg/60 mL multi-dose vials (the previous update of Teva's cisplatin supply remains the same with the 1 mg/mL 50 and 100 mL MDVs).
May 19, 2023, Cisplatin & Carboplatin Availability Update: Accord will release on-hold supply of cisplatin. It will release carboplatin too. This will help fill the supply gap until other manufacturers have releases. The FDA continues to explore all avenues to meet demand, including temporary importation.
May 17, 2023, Cisplatin Availability Update: Teva has a limited supply of the smaller 50mL vials of cisplatin and availability of the 100mL, with recovery to regular supply levels expected in Q4 and Q3, respectively. Call 800-545-8800 for details.
May 12, 2023, Cisplatin Availability Update: Accord released an additional cisplatin supply which should be available to order in the coming days. Accord also plans releases soon for carboplatin and methotrexate. FDA continues to work with all companies on increased supply, as well as pursuing importation.
Drug Shortage Listings
The FDA maintains a list of drugs in shortage with information on expected duration of shortage and alternative suppliers, when available.
The American Society of Health-System Pharmacists (ASHP) also maintains a list of drugs in shortage with information on the expected duration of shortage and alternative suppliers, when available. This list differs from the FDA’s list as ASHP lists every drug shortage reported through their online report form as soon as it is investigated and confirmed, usually within 24-72 hours, whereas the FDA site focuses only on shortages of medically necessary drugs, as these have the potential to impact public health.
Reporting Shortages
ASCO strongly encourages all members to report drug shortages directly to FDA so that they understand the volume and scope of the problem and can best direct their attention.
Answers to questions about oncology drug shortages published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) for voluntary, informational use by providers in the rapidly evolving drug shortage crisis. This information does not constitute medical or legal advice, is not intended for use in the diagnosis or treatment of individual conditions, does not endorse products or therapies, recommend or mandate any particular course of medical care, and is not a statement of the standard of care. New evidence may emerge between the time information is developed and when it is published or read. The information is not comprehensive or continually updated. This information is not intended to substitute for the independent professional judgment of the treating provider in the context of treating the individual patient. ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions. Use of the information is subject to the complete ASCO website Terms of Use.