Introduction

Practical Steps for Practitioners Facing Drug Shortage Situations

More Information on Drug Shortages, Product Recalls and Warnings

Comments on this Web Page

Introduction

Practical Steps for Practitioners Facing Drug Shortage Situations

More Information on Drug Shortages, Product Recalls and Warnings

Other Drug Shortage Links

Comments on this Web Page

Drug Shortages

Introduction
FAQs (7/23/2008)
Important Information about Albuterol Metered Dose Inhalers (MDIs) Transition (5/30/2009)
Current Drug Shortages (9/12/2008)
Resolved Drug Shortages (7/11/2008)
Drugs to be Discontinued (8/5/2008)
Additional Communications (9/23/2005)
Drug Shortage Manual of Policies and Procedures (MaPP)
Medical Necessity Guidance Document
How to Report a Drug Shortage
Practical Steps for Practitioners Facing Shortage Situations
More Information on Drug Shortages, Product Recalls and Warnings
Other Sites
Comments on this Web Page

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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

IMPORTANT INFORMATION ABOUT ALBUTEROL METERED DOSE INHALERS (MDIs) TRANSITION

Albuterol Metered Dose Inhalers - After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available.

Additional information on CFC and MDIs:

Albuterol HFA and levalbuterol HFA metered dose inhalers are available from the following firms:

Albuterol Metered Dose Inhalers:

Schering Plough: PROVENTIL-HFA (NDC 00085-1132-01). Schering-Plough has established a special CFC to HFA transition toll free hotline at 1-877-HFA-7768

GlaxoSmithKline: Ventolin-HFA (NDC# 0173-0682-20) - Customer service number 1-888-825-5249

IVAX Laboratories, Inc.: ProAir HFA (Albuterol Sulfate HFA): NDC 59310-579-20. If you have any questions, please call 1-888-482-9522

Levalbuterol Metered Dose Inhalers:

Sepracor: Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol metered dose inhalers (NDC 63402-510-01) - Customer service 1-888-394-7377

Current Drug Shortages

Drug Name

Company
Information

Reason for Shortage

Related Information

Fentanyl transdermal patch

updated 6/20/2008

Recalls by the following firms:

Actavis: 877-422-7452

PriCara: 800-547-6446

Sandoz Inc: 800-901-7236

Fentanyl transdermal patches have been recalled by separate manufacturers, with specific lots and reasons below.

Actavis has recalled all lots and strengths of their fentanyl transdermal patches. Actavis press release with additional information

Pricara and Sandoz Inc. have recalled all lots of their 25 mcg/hr patch product: more information.

Fentanyl transdermal patches continue to be available from the following firms:

Mylan: 12.5, 25, 50, 75, 100 mcg/hr patches available Customer service: 800-796-9526
Pricara: Customer service: 800-526-7736
Sandoz: Customer service: 800-525-8747
Watson: Customer service: 973-355-8300

Heparin sodium injection multidose and single dose vials from Baxter and heparin sodium large volume infusion solutions from B. Braun

updated 4/15/2008

Baxter Healthcare
888-229-0001

B. Braun
800- 227-2862

Baxter has recalled all lots of multi-dose and single-dose vials, and all heparin flush products. B. Braun has recalled all heparin sodium large volume infusion solutions.

Recall information from Baxter.

Recall information from B. Braun.

Heparin sodium injection products remain available from these suppliers:

APP: 888-386-1300
additional APP ordering information

Hospira: 877-946-7747

Baxter Healthcare 888-229-0001 (Please note Baxter's recall does not involve their heparin sodium large volume infusion solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection).

Additional heparin information

Methadone Hydrochloride Injection

updated 8/19/2008

Xanodyne Pharmaceuticals, Inc.

Manufacturing Delays

Please call Xanodyne at 1-877-926-6396 to inquire about emergency supplies or to request additional information.

MVI Adult Injectable

updated 6/20/2008

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: (updated 6/20/2008)

Neupro (rotigotine transdermal system)

updated 7/9/2008

UCB, Inc
800-477-7877

UCB has recalled all domestic lots

Additional information on the recall and instructions for providers and patients currently on Neupro are located below.

Neupro Patient Information

Neupro Physician Information

Phospholine Iodide, Ophthalmic solution 0.125%

8/11/2008 (updated)

Wyeth

Manufacturing delays

Sold on a limited basis to physicians and pharmacists.

Please call 1-800-666-7248 for additional information.

Dear Health Care Provider Letter

Proglycem (diazoxide) oral suspension

updated
7/24/2008

Teva Pharmaceuticals 1-888-TevaUSA

Manufacturing delays

Teva is managing inventory and can provide product from their emergency supply.

Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800.

Emergency requests can be made after hours by calling 800-795-2652

Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243

updated 9/12/2008

Mallinckrodt Inc. 888-744-1414

see "Related Information"

Updated letter Letter from Mallinckrodt

Lantheus Medical Imaging continues to supply TechneLite (Technetium Tc99m) Generators, but market shortage is projected. Lantheus customer service: 800-299-3431

Valstar (valrubicin) Solution for Intravesical Instillation

updated 7/9/2008

Indevus Pharmaceuticals
Cranbury, NJ
Customer Service:
888-282-5372

Product was previously discontinued

Indevus Pharmaceuticals plans to re-introduce product to market.

Zanosar (Streptozocin) 1gm/vial Injection

updated 8/26/2008

Teva Parenteral Medicines, Inc.

Manufacturing delays

Please call 1-888-TevaUSA for additional information.

Resolved Drug Shortages

Drug Name	Company Information	Related Information
A-methapred (methylprednisolone sodium succinate) for injection 125mg and 40mg 1/24/2008	Hospira 877-946-7747	No further supply issues are anticipated.
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
BiCNU (carmustine) Injection updated 4/2/2008	Bristol-Myers Squibb 800-631-5244	No further supply issues are anticipated. Letter from Bristol-Myers Squibb
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 )
Cyclophosphamide 25mg (NDC 00054-4129-25) 50mg (NDC 00054-4130-25) 1/24/2008	Roxane Laboratories, Inc. 614-276-4000	Cyclophosphamide tablets are available through normal distribution. 25mg tablets were released on 1/23/2008.
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
Digoxin oral tablets updated 7/11/2008	Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). recall notice GlaxoSmithKline, Lannett, West-Ward, and Caraco continue to supply digoxin tablets.	GlaxoSmithKline (888-527-6933) continues to have Lanoxin 0.125mg and 0.25 mg tablets available. Lannett (customer service # 215-333-9000) reports availability of digoxin 0.125mg and 0.25mg tablets. West-Ward (customer service # 800-631-2174) is continuing to ship product as it becomes available. Caraco (customer service # 313-871-8400) is continuing to ship product as it becomes available
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.
Indocyanine Green for Injection, USP (IC-GREEN) 11/21/2007	Akorn, Inc. 800-932-5676	No further supply issues are anticipated
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
Leukine (sargramostim) liquid 500 mcg vial 5/29/2008	Berlex Laboratories (Announcement from Bayer HealthCare Pharmaceuticals)	Dear Healthcare Professional Letter
Levothyroxine sodium lyophilized powder for injection. updated 6/9/2008	Bedford Laboratories 800-562-4797 APP 888-386-1300	Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again
Lymphazurin 1% injection (isosulfan blue) 4/28/2008	Covidien (formerly U.S. Surgical) 1-203-845-1000	Covidien now has Lymphazurin 1% injection available.
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
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.
Solu-Cortef 100mg (hydrocortisone sodium succinate) for injection 11/21/2007	Pfizer, Hospira	Pfizer reports all presentations are available and Hospira reports the 100mg presentation is available. Supplies anticipated to continue to meet demand.
TABLOID (Thioguanine) 40 mg Tablets 1/26/2005	GlaxoSmithKline	Please call GSK for additional information at 1-888-527-6933
Tc99: Multiple diagnostic products which utilize Tc99 generators 1/3/2008	Bristol Myers Squibb Medical Imaging; Covidien Imaging Solutions	No further supply issues anticipated
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.
Tikosyn (0.5mg and 0.25mg capsules)	Pfizer Inc. 800-438-1985	Dear Healthcare Professional Letter
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

Discontinuations

Companies are required under 21 CFR 314.81(b)(3)(iii) to provide FDA with a six month advance notice 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 updated 10/10/2007	GlaxoSmithKline 888-825-5249	Letter from GlaxoSmithKline (updated 10/10/2007)
5% Alcohol in 5% Dextrose Injection, USP, Glass Container 12/19/2007	Hospira, Inc. 877-946-7747	Hospira has made a business decision to discontinue manufacturing of 5% Alcohol in 5% Dextrose Injection drug product (NDC# 0409-1500-05)
Brevibloc Concentrate (esmolol HCl) 250 mg/mL, 10 mL ampul 8/24/2007	Baxter Healthcare Corporation	Baxter Healthcare Corporation has made a decision to discontinue Brevibloc Concentrate (esmolol HCl) 250 mg/mL, 10 mL ampul (NDC 10019-025-18 for the pack and NDC 10019-025-73 for the ampul). Letter from Baxter
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).
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) 6/5/2008	King Pharmaceuticals 800-776-3637	Letter from King Pharmaceuticals
Cortisporin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) 6/5/2008	King Pharmaceuticals 800-776-3637	Letter from King Pharmaceuticals
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
Cytoxan (cyclophosphamide) 25mg and 50mg tablets 9/24/2007	Bristol-Myers Squibb Company 609-897-2412	Bristol-Myers Squibb Company has made a decision to discontinue Cytoxan (cyclophosphamide) 25mg and 50mg tablets. Alternate products continue to be available from other companies.
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.
Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection 2/29/2008	Baxter Healthcare Corporation	Letter from Baxter Healthcare Corporation
Ethmozine (moricizine hydrochloride) 200mg, 250g, and 300mg tablets updated 9/17/2007	Shire US Inc. 725 Chesterbrook Blvd. Wayne, Pa 19087 1-800-828-2088	Dear Healthcare Professional Letter
Exubera (insulin recombinant human, powder for inhalation) 10/19/2007	Pfizer 800-398-2372	Dear Healthcare Provider 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
Geocillin (carbenicillin indanyl sodium) tablets 382 mg 4/8/2008	Pfizer	Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets.
Geref Diagnostic (sermorelin acetate for injection) 0.05mg base/amp updated 8/5/2008	EMD Serono 1-888-398-4567	EMD Serono has made a business decision to discontinue this product. Dear Healthcare Professional Letter
Humatin (Paromomycin Sulfate Capsules, USP) 2/7/2008	King Pharmaceuticals Professional Information Services Department 800-776-3637	King Pharmaceuticals has made a decision to discontinue Humatin (Paromomycin Sulfate Capsules, USP) Paromomycin continues to be available from another manufacture. Letter from King Pharmaceuticals
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
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) 6/2/2008	King Pharmaceuticals 800-776-3637	Letter from King Pharmaceuticals.
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
Kemadrin (procyclidine hydrochloride) 6/6/2008	King Pharmaceuticals 800-776-3637	Letter from King Pharmaceuticals
Lanoxin Elixir(digoxin) 6/3/2005	GlaxoSmithKline	This product has been discontinued by GSK. Roxane is producing digoxin elixir.
LEXXEL (enalapril maleate-felodipine ER) Tablets 12/19/2007	AstraZeneca LP (AstraZeneca) - Contact Corporate Information Center at 800-236-9933.	LEXXEL Tablets will be discontinued on July 31, 2008. AstraZeneca has no further plans to manufacture or distribute LEXXEL (enalapril maleate-felodipine ER) Tablets after July 31, 2008.
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	Dear Doctor Letter Patient Information Frequently Asked Questions
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.
Procanbid (Procanamide Hydrochloride Extended-Release Tablets) 11/9/2007	King Pharmaceuticals 800-776-3637	Dear Prescriber Letter
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	Dear Doctor Letter Patient Information Frequently Asked Questions
Revex (Nalmefene HCl Injection) 1mg/mL, 2 mL ampule and 0.1mg/mL, 1mL ampule 7/9/2008	Baxter Healthcare Corporation 888-229-0001	Baxter has discontinued Revex production.
Roferon-A (Interferon alfa-2a, Recombinant) 11/29/2007	Hoffmann -La Roche Inc. 800-526-6367	Dear Healthcare Professional Letter
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
Sporanox (itraconazole) Injection 10/11/2007	Ortho Biotech	Please see Dear Health Care Professional letter for additional information
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)
Tenormin (atenolol) 0.5mg/ml Injection 2/28/2008	AstraZeneca Pharmaceuticals LP (AstraZeneca) – Contact Corporate Information Center: 800-236-9933	AstraZeneca has made a business decision to discontinue Tenormin (atenolol) 0.5 mg/ml injection.
Teslac (testolactone tablets, USP) 50mg tablets 2/26/2008	Bristol-Myers Squibb 609-897-2412	Bristol-Myers Squibb Company has made a decision to discontinue Teslac (testolactone tablets, USP) 50mg tablets. Letter from Bristol-Myers Squibb
Tequin (gatifloxacin) Tablets and Injection 5/12/2006	Bristol-Meyers Squibb	See attached letter.
Tilade Inhaler (nedocromil sodium inhalation aerosol) 5/2/2008	King Pharmaceuticals 800-776-3637	Dear Healthcare Professional Letter (4/30/2008)
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
Zyflo (zileuton) tablets 2/20/2008	Critical Therapeutics, Inc.	Zyflo CR continues to be available. Dear Healthcare Professional Letter

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).

Letter to Doctors

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

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.

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.

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.

FDA Product Recalls, Alerts, and Warnings. FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties.
Cderrecalls@cder.fda.gov or phone 301-827-9045

We ask you to take time to communicate with CDER about this website. Please email us at drugshortages@fda.hhs.gov with feedback about this site.

Last Updated: September 12, 2008

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