 | Drug Shortages It is FDA's policy to help prevent or alleviate shortages primarily of medically necessary drug products, since these can have significant public health consequences. A drug shortage may involve either an actual or a potential shortage of a drug product. A 1997 FDA Consumer article "Inside FDA: When a Drug is in Short Supply" provides background information and an example of how FDA manages drug shortages. The article "FDA's Role in Responding to Drug Shortages? published in the American Journal of Health Systems Pharmacists {2002 Aug 1;59(15):1423-5}, provides additional information. Frequently Asked Questions Current Drug Shortages | Drug Name | Company
Information | Reason for Shortage | Related Information | Albuterol Metered Dose Inhalers- (3/9/2006; GSK updated 6/28/2006, IVAX updated 7/12/2006, Albuterol metered dose inhalers, both HFA and CFC inhalers, are made by multiple manufacturers. Even though total albuterol supplies (HFA and CFC) are currently meeting market demand, supplies of HFA albuterol metered dose inhalers continue to increase relative to supplies of CFC inhalers. Therefore, HFA inhalers may need to be substituted for CFC inhalers as the shift towards increased HFA inhalers continues to occur. Please note CFC albuterol inhalers will be completely withdrawn from the market by December 31, 2008 -see http://www.fda.gov/cder/mdi/mdifaqs.htm for further information.
The following firms are currently producing albuterol and levalbuterol metered dose inhalers. FDA considers all of these inhalers as options for patients who cannot otherwise get their preferred albuterol brand or product:
Albuterol Metered Dose Inhalers Schering Plough: On October 13, 2006 Schering-Plough, through its Warrick Pharmaceutical Division, announced that in compliance with the Montreal Protocol and its mandate to remove ozone-depleting substances, they will begin to transition their supply of CFC-based albuterol inhalers to PROVENTIL HFA (an HFA-based albuterol inhaler). As Schering decreases the supply of CFC-based albuterol inhalers, they will increase the supply of PROVENTIL HFA inhalers. Schering expects that they will have the capacity to provide their historical volume of albuterol inhalers. This reduction in CFC inhaler supply to the market will begin November 1, 2006. Warrick Pharmaceuticals intends to cease manufacturing CFC inhalers in early 2007. FDA has been working closely with Schering-Plough to help ensure a smooth transition with patient safety and access to albuterol inhalers as the primary concern. Replacement of CFC albuterol inhalers with an HFA inhaler will generally require a new prescription. Schering-Plough has established a special CFC to HFA transition toll free hotline at 1-877-HFA-7768 or you can visit their website at WWW.PROVENTILHFA.COM for further information. Schering-Plough supplies Proventil (NDC 00085-0614-02), Warrick - albuterol MDI (NDC 59930-1560-01) and PROVENTIL-HFA (NDC 00085-1132-01).
GlaxoSmithKline - Ventolin-HFA (NDC# 0173-0682-20) - continues to be available.. Customer service number 1-888-825-5249 (updated 6/28/2006) IVAX Laboratories, Inc. has available ProAir HFA (Albuterol Sulfate HFA): NDC 59310-579-20. If you have any questions, please call 1-888-482-9522. (updated 7/12/2006) Armstrong Pharmaceuticals albuterol metered dose inhalers (NDC 17270-0721-01). Customer service- 1 (800) 423-4136
Levalbuterol metered dose inhalers:
Sepracor - Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol metered dose inhalers (NDC 63402-510-01). Customer service 1-888-394-7377
FDA will continue to closely monitor this situation and will continue to work with the manufacturers on issues related to increasing supplies.
| | BiCNU (carmustine) Injection updated 11/8/2005
| Bristol-Myers Squibb
800-631-5244 | Manufacturing pending
| Update from BMS  (updated 11/8/2005) | Indocyanine Green for Injection, USP (IC-GREEN) updated 7/13/2007  | Akorn, Inc. | See "Related Information" | Akorn has filed a manufacturing site change supplement for IC GREEN with the Food and Drug Administration, and is working with the FDA Drug Shortage team and the CDER Review Division to return this product to market. Akorn’s customer service number is 800-932-5676. Extension of Expiration- FDA has approved a supplement to extend the expiration of IC-Green lots with a printed expiration date prior to April 2007 by 12 additional months beyond the printed date. Akorn webpage posting from July 12, 2007 with additional information.
| Lymphazurin 1% injection (isosulfan blue) 6/12/2006 | US Surgical | Shortage of raw materials | US Surgical and FDA working to resolve the shortage. Product remains available on allocation - please see Dear Customer letter (letter updated 6/6/2007) for additional information. | MVI Adult Injectable 7/12/2007 | Hospira
877-946-7747 Baxter
888-229-0001
| Manufacturing Delays
| Baxter continues to have Infuvite Adult single dose (NDC# 54643-5649-1) and Infuvite Adult bulk dose (NDC# 54643-5649-2) available. Hospira reports the following: | Solu-Cortef 100mg (Hydrocortisone sodium succinate) for injection 4/4/2007 | Pfizer, Hospira
| Manufacturing delays | Pfizer reports that Solu-Cortef (hydrocortisone sodium succinate) 100mg injection is on backorder until middle of June 2007. The 250mg, 500mg, and 1gm vials continue to be available. Please call Customer Service (800) 533-4535 if you have additional questions.
Hospira has A-Hydrocort® (hydrocortisone sodium succinate) Injection, USP 100 mg vials (NDC# 00409-4856-05) available. Please call Hospira at 1-877-946-7747 for additional information.
| Solu-Medrol 125mg (methylprednisolone sodium succinate) for injection 4/4/2007 | Pfizer, Abraxis Pharmaceutical Products, Hospira, Bedford | Manufacturing delays
| Pfizer reports that Solu-Medrol (methylprednisolone sodium succinate) 125mg vials are on backorder until middle of June 2007. The 40mg, 500mg, 1gm, and 2gm vials continue to be available. Please call Customer Service (800) 533-4535 if you have additional questions.
Abraxis Pharmaceutical Products (APP) has methylprednisolone sodium succinate injection available in 1 gram vials (63323-265-03), 125 mg vials (NDC #63323-258-03) and 40 mg vials (NDC# 63323-255-03). Please call APP at 1-888-386-1300 Option 2 for additional information.
Hospira has A-Methapred® (methylprednisolone sodium succinate) for Injection, USP 125 mg (NDC# 00409-3218-05) and
40 mg vials (NDC# 00409-3217-05) available. Please call Hospira at 1-877-946-7747 for additional information. Bedford has methylprednisolone sodium succinate injection available in 125mg (NDC# 55390-209-10 ) carton of 10, 40mg (NDC# 55390-210-10 ) carton of 10, 500mg (NDC# 55390-218-01) Individually boxed, and 1gm (NDC# 55390-219-01 ) Individually boxed. Please call Bedford at 1-800-562-4797 for additional information
| | Valstar (valrubicin) Solution for Intravesical Instillation updated 2/22/2007 | Valera Pharmaceuticals, Inc
Cranbury, NJ
Customer Service:
888-282-5372
| Product was previously discontinued | As of April 2006, Valera acquired the rights to manufacture, market and distribute Valstar, and plans on re-introducing the product in the U.S. by 3rd quarter 2007. |  Back to Top Resolved Drug Shortages | Drug Name | Company Information | Related Information | | Amphotericin B injection 2/23/2005 | X-GEN (formerly Pharma-Tek), Sandoz
| Amphotericin B injection is now available through normal distribution.
| | Avonex (interferon Beta 1a) 4/12/2005
| Biogen Idec
800-456-2255 | No further supply issues are anticipated.
| Bicillin L-A (penicillin G benzathine) Injection 11/27/2006 | King Pharmaceuticals, Inc. | Letter from King Pharmaceuticals | | Cortrosyn Injection (Cosyntropin) 0.25mg/vial 1/19/2005 | Amphastar | Cortrosyn is now available through normal distribution. Please call Customer Service at 1-800-423-4136 for additional information.
| | Celestone Soluspan 4/6/2006 | Schering-Plough Corp.
2000 Galloping Hill Rd.
Kenilworth, NJ 07033-0530
908-298-4000
800-526-4099
| Celestone Soluspan is now available through normal distribution channels. | | Coreg (carvedilol) tablets 5/3/2006 | GlaxoSmithKline | Coreg is now available through normal distribution channels.
(please see attached letter for additional information )
| | Cytovene (ganciclovir) Powder for Injection 4/5/2005 | Roche Professional Product Information Department
800-526-6367 | Cytovene IV shortage has been resolved and no further supply problems are anticipated | | Fluorouracil Injection 4/10/2006 | APP | 5FU Available Presentations:
NDC#: 63323-117-10
Strength = 500mg
Vial Size = 10 mL
NDC#: 63323-117-20
Strength = 1 gm
Vial Size = 20 mL NDC#: 63323-117-51
Strength = 2.5g
Vial Size = 50 mL
NDC#: 63323-117-61
Strength = 5g
Vial Size = 100mL | Hydralazine Hydrochloride Injection, USP 2/5/2007 | Luitpold Pharmaceuticals (American Regent) and Abraxis | Luitpold Pharmaceuticals (American Regent) and Abraxis currently have all hydralazine products available. | Ketalar CIII (ketamine hydrochloride for injection, USP) 10mg/ml (20mL vial) 5/1/2007 | King Pharmaceuticals, Inc. (800) 668-4391 | Ketalar 10mg/ml (20ml vial) is now available through normal distribution | | Marplan (isocarboxazid) 10 mg 5/20/2005 | Oxford Pharmaceutical
877-284-9120 | Marplan will resume normal distribution 5/27/2005
| | Maxipime (cefepime) 6/19/2006 | Elan Pharmaceuticals
800-859-8586 | Maxipime is now available through normal distribution. | | MERREM IV (meropenem for injection) 4/6/2006 | AstraZeneca Pharmaceuticals LP
(Corporate Information Center
800-236-9933
| AstraZeneca has removed the allocation for MERREM for the 1gram/30 ml vials (NDC 0310-0321-30) and the
500 mg/20 ml vials (NDC 0310-0325-20.
| | Methotrexate injection updated 3/17/2006 | Mayne Pharma
866-594-8420 | Please be sure to use new NDC numbers | Bedford
1-800-562-4797 | | American Pharmaceutical
Partners
888-386-1300 | Methotrexate injection available from APP: NDC#: 63323-123-02
Strength = 25mg/ml
Vial Size = 2mL NDC#: 63323-123-10
Strength = 25mg/ml
Vial Size = 10 mL
| | Proglycem oral suspension 6/19/2006 | IVAX/TEVA | Proglycem oral suspension is now available through normal distribution. | Reserpine Tablets (0.1 and 0.25 mg) 11/27/2006 | Sandoz Inc.
1-800-525-8747 | Sandoz reports that reserpine tablets are again available. | | TABLOID (Thioguanine) 40 mg Tablets 1/26/2005 | GlaxoSmithKline | Please call GSK for additional information at 1-888-527-6933
| | Thiola (tiopronin) 100 mg tablets 1/3/2005 | Mission Pharmacal Customer Service
800-292-7364
| Thiola is now available from pharmacies through normal distribution. Please contact Mission Pharmacal at 1-800-292-7364 for additional information.
| | Trecator SC (ethionamide) 250 mg tablets 4/1/2005
| Wyeth | Trecator SC is now available through normal distribution.
| | Zemuron (rocuronium bromide) injection, 5 ml and 10 ml vials 2/7/2005
| Organon Pharmaceuticals USA Inc.
800-241-8812 | Please call Organon Customer Service at 1-800-241-8812 for additional information
| | Zyflo Filmtab (Zileuton) Tablets 11/17/2005 | Critical Therapeutics
866-835-8216
| Zyflo is now available through Clinical Therapeutics. | Back to Top Discontinuations | The Food, Drug and Cosmetic Act requires companies to give FDA a six-month notification of the discontinuation of sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition.. From time to time, FDA also receives notification for other products. These discontinuations are provided below for informational purposes only. | To locate drugs that have already been discontinued, please consult the following:
Drugs@FDA
Orange Book Query
Orange Book Monthly Additions and Deletions | Drug Name | Company Information | Related Information | | Agenerase (amprenavir) 150mg capsule 9/17/2004 | GlaxoSmithKline
888-825-5249 | Letter from GlaxoSmithKline | | Calciferol injection in oil (ergocalciferol) 3/19/2004 | Schwarz Pharma
6140 W. Executive Drive
Mequon, WI 53092
800-558-5114
| Schwarz has discontinued manufacturing of calciferol
| | CEFOTAN (cefotetan injection) 6/9/2006 | AstraZeneca Pharmaceuticals LP (AstraZeneca) - Contact Corporate Information Center at 800-236-9933. | The remaining inventory of CEFOTAN (cefotetan
injection) has been depleted. AstraZeneca has no further plans to manufacture or distribute CEFOTAN (cefotetan injection). | | Cylert (pemoline) tablets and chewable tablets, all strengths 5/25/2005
| Abbott Laboratories
| Abbott has made the decision to discontinue Cylert tablets and chewable tablets Letter from Abbott | | Desyrel (trazodone) Tablets 50mg, 100mg, 150mg and 300mg tablets 9/21/2006 | Bristol-Myers Squibb Company
609-897-2412 | Alternate products continue to be available from other companies. Dear Healthcare Professional Letter | | ELAVIL (amitriptyline hydrochloride) Tablets and Injection. 5/15/2003 | AstraZeneca Pharmaceuticals LP (AstraZeneca) ? Contact Corporate Information Center at 800-236-9933 | ELAVIL Injection is no longer available at AstraZeneca. The remaining inventory of ELAVIL Tablets will be depleted by December 31, 2003. AstraZeneca has no further plans to manufacture ELAVIL (amitriptyline hydrochloride) Tablets or Injection. | Ethmozine (moricizine hydrochloride) 200mg, 250g, and 300mg tablets 7/30/2007  | Shire US Inc.
725 Chesterbrook Blvd.
Wayne, Pa 19087
1-800-828-2088 | Dear Healthcare Professional Letter | Florinef (fludrocortisone acetate tablets, USP) 6/8/2007 | King Pharmaceuticals, Inc. 501 Fifth Street Bristol, Tennessee 37620 Professional Information Services Department:
800-776-3637 | Dear Healthcare Provider Letter | | Flovent Rotadisk (fluticasone propionate inhalation powder) 8/31/2004 | GlaxoSmithKline
888-825-5249 | Please see Dear Healthcare Professional letter for additional information.
| | Fortovase (saquinavir) capsules 200 mg 6/2/2005 | Roche | Fortovase 200 mg capsules will be discontinued by February 15, 2006. Please see attached DHP letter for additional information. Dear Healthcare Professional Letter
| | Humulin U ULTRALENTE (HUMAN INSULIN [rDNA ORIGIN] EXTENDED ZINC SUSPENSION) 7/6/2005 | Eli Lilly and Company | Dear Doctor Letter Patient Information | | Humulin L LENTE (HUMAN INSULIN [rDNA ORIGIN] ZINC SUSPENSION) 7/6/2005 | Eli Lilly and Company | Dear Doctor Letter Patient Information | | HIVID (zalcitabine) tablets 7/26/2006 | Roche Pharmaceuticals | The sale and distribution of its anti-HIV
medication HIVID (zalcitabine) Tablets will be discontinued by December 31, 2006.Dear Health Care Professional Letter | | Inulin in Sodium Chloride Injection, USP 9/26/2003
| Questcor Pharmaceuticals, Inc. | Letter | | Kefzol (cefazolin) all presentations 2/28/2003 | Eli Lilly and Company | Letter | | Kefurox (cefuroxime) all presentations 2/28/2003 | Eli Lilly and Company | Letter | | Lanoxin Elixir(digoxin) 6/3/2005 | GlaxoSmithKline | This product has been discontinued by GSK.
Roxane is producing digoxin elixir.
| | Lorabid (loracarbef, USP) capsules and suspension 10/27/2006 | King Pharmaceuticals 888-840-5370 | Letter from King Pharmaceuticals | | Mandol (cefamandole) all presentations 2/28/2003 | Eli Lilly and Company | Letter | | Mivacron (mivacurium chloride) injection 6/23/2006 | Abbott Laboratories | Alternative products that can be used in place of Mivacron continue to be available. Please call Abbott at 1-800-633-9110 for additional information.
.
| Neutrexin (trimetrexate glucuronate) Injection 6/14/2007 | MedImmune, Inc. | Dear Healthcare Professional Letter | | Nolvadex (tamoxifen citrate) 4/10/2006
| AstraZeneca
800-236-9933 | Letter | | Novolin L, Lente, human insulin zinc suspension [rDNA origin] 7/15/2003 | Novo Nordisk Pharmaceuticals, Inc. Contact:
800-727-6500 Customer Service | Letter | | NPH Iletin II (ISOPHANE INSULIN SUSPENSION, USP, PURIFIED PORK) 7/6/2005 | Eli Lilly and Company | | | ORLAAM (Levomethadyl hydrochloride acetate) Oral Solution, 10 mg/mL 9/2/2003 | Roxane Laboratories | Letter | | Pancrease (pancrelipase) capsules updated 5/17/2006 | McNeil Consumer and Specialty Pharmaceuticals
888-440-7903 | Other pancrelipase products continue to be available Dear Health Care Provider Letter
| | Perchloracap (potassium perchlorate) 200 mg capsules 6/2/2005 | Tyco Healthcare | Perchloracap capsules have been discontinued and supplies are anticipated to be depleted by the end of 2005. | | Pre-Pen (benzylpenicilloyl polylysine) injection 4/13/2005 | Hollister-Stier
800-992-1120
| Pre-Pen is no longer available. | ProSom (estazolam) Updated 5/2/2007 | Abbott
200 Abbott Park Road Abbott Park, IL 60064-6157
Customer Service: 800-633-9110 | Dear Health Care Provider Letter | Pulmicort Turbuhaler 200mcg (budesonide inhalation powder) 5/16/2007 | AztraZeneca
1800 Concord Pike PO Box 8355 Wilmington DE 19803-8355
Corporate Information:
800-842-9920 | NDA 20-441, PULMICORT TURBUHALER 200 mcg (budesonide inhalation powder) will no longer be available at AstraZeneca. The introduction of PULMICORT FLEXHALER (budesonide inhalation powder, 90 & 180 mcg), NDA 21-949, will be accompanied by the phasing out of PULMICORT TURBUHALER so as to minimize confusion in the marketplace. AstraZeneca has no further plans to manufacture NDA 20-441, PULMICORT TURBUHALER 200 mcg (budesonide inhalation powder). | | Regular Iletin II (INSULIN INJECTION, USP, PURIFIED PORK) 7/6/2005 | Eli Lilly and Company | | | Serevent Inhalation Aerosol 6/10/2003 | GlaxoSmithKline
800-340-3236 | GSK anticipates that SEREVENT Inhalation Aerosol will no longer be available starting in June 2003. Dear Health Care Professional Letter from GlaxoSmithKline | | Stelazine (trifluoperazine) oral concentrate 10mg/ml Stelazine (trifluoperazine) tablets (1mg, 2mg, 5mg, 10mg) Stelazine (trifluoperazine) Injection 2mg/ml 12/18/2003 | GlaxoSmithKline
888-825-5249 | Stelazine was discontinued and withdrawn from the market. The final lots were distributed by GSK August 2003 and the final expiry date of all products in the marketplace is no later than January 31, 2004.
| | Suprax (cefixime) updated 2/25/2004 | Lederle/Wyeth Pharmaceuticals | Discontinued July 2002. Stock will be distributed until exhausted or until March 2003, whichever comes first. For additional information, please call customer service (800) 666-7248 Lupin Pharmaceuticals recently received approval for cefixime 400 mg tablets and cefixime 100 mg/5 ml suspension. For further information, please contact Lupin Pharmaceuticals at 410-576-2000 (2/25/2004) | | Tequin (gatifloxacin) Tablets and Injection 5/12/2006 | Bristol-Meyers Squibb
| See attached letter. | | Valstar (valrubicin) Solution for Intravesical Instillation 1/30/2004 | Formerly distributed by Celltech
Celltech Customer Service
888-963-3382
| No further availability planned at this time. | | Velosulin BR Human, Buffered Regular Human Insulin Injection [rDNA origin] 11/3/2003
| Novo Nordisk Pharmaceuticals, Inc.
Contact:
800-727-6500
Customer Service
| Dear Healthcare Professional Letter | | Videx (didanosine) chewable/dispersable buffered tablets 9/19/2006 | BMS | Dear Healthcare Professional Letter
| | 1.5% Xylocaine -MPF with Dextrose 7.5% Injection (lidocaine HCl and dextrose anhydrous Injection ampules) 8/29/2005
| AstraZeneca
800-842-9920
| 1.5% Xylocaine? -MPF with Dextrose 7.5% Injection is no longer available at AstraZeneca. The remaining inventory of 1.5% Xylocaine? -MPF with Dextrose 7.5% Injection Ampules will be depleted by August 31, 2005. AstraZeneca has no further plans to manufacture 1.5% Xylocaine? -MPF with Dextrose 7.5% Injection Ampules
| | Zovirax (acyclovir sodium) for injection 1000mg/20ml vial 1/6/2004 | GlaxoSmithKline
Customer Service
800-877-1158
| Letter from GSK | Back to Top Additional Communications Distribution Changes for Lamprene (clofazimine) (5/4/2005)
Please see the attached letter from Novartis Pharmaceuticals Corporation for information about distribution changes for Lamprene (clofazimine). | | On May 20, 2005, Praecis Pharmaceuticals announced that it is voluntarily discontinuing the sale of Plenaxis to new patients in the United States for economic reasons. Patients currently on Plenaxis therapy may continue to receive the drug. Please see Plenaxis Information page for additional information. (6/3/2005) | Drug Shortage Manual of Policies and Procedures (MaPP) MaPPs are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. MaPPs define external activities as well. All MaPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities, and procedures. - MaPP 6003.1 Drug Shortage Management
Back to Top Medical Necessity A product is considered to be medically necessary, or a medical necessity, if it is used to treat or prevent a serious disease or medical condition, and there is no other available source of that product or alternative drug or therapy that is judged by medical staff to be an adequate substitute. Patient "inconvenience" alone is an insufficient basis to classify a product as a medical necessity. Back to Top How to Report a Drug Shortage To report a CDER product by email: drugshortages@cder.fda.gov To report a CDER product by phone: CDER Drug Information (888) INFOFDA or (888) 463-6332, or (301) 827-4570 To report a CBER product shortage (biological and related products including blood, vaccines, tissue, allergenics), by e-mail: CBERProductshortages@cber.fda.gov To report a CBER product shortage (biological and related products including blood, vaccines, tissue, allergenics), by phone during business hours, biological product manufacturers and healthcare personnel may report a real or suspected biological product shortage by calling (301) 827-6220.
To report a CDRH or CFSAN shortage to FDA, see listings under FAQs
To report a shortage to ASHP you may use the Drug Product Shortages Report form (non-FDA site) available from the American Society of Health-Systems Pharmacists (ASHP) web page. When you use this form, you are reporting a drug shortage to ASHP, not FDA. CDER partners with ASHP to minimize drug shortages and report rapid accurate drug shortage information. Back to Top Practical Steps for Practitioners Facing Drug Shortage Situations - ASHP Guideline on Managing Drug Shortages. The American Society of Health-System Pharmacists guideline describes the contributing factors to drug product shortages and recommends a general process for inventory management in preparation for and working through shortage situations.
Back to Top More Information on Drug Shortages, Product Recalls and Warnings Other Drug Shortage Links Comments on this Web Page | | We ask you to take time to communicate with CDER about this website. Please e-mail us at drugshortages@cder.fda.gov with feedback about this site. |  Back to Top  Back to Drug Information
Last Updated: July 30, 2007 | |
