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Drug Shortages 

Drug Shortages Email AlertSubscribe Sign up for an E-mail notification to receive updates of drug products added to the Current Drug Shortages, and Resolved Drug Shortages lists.

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Introduction

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

Alprostadil 0.5 mg/mL injection

12/9/2008

Teva Pharmaceuticals

Bedford

Pfizer, Inc. (Prostin VR Pediatric Injection)

Teva Pharmaceuticals: Manufacturing delays

Bedford: Manufacturing delays

Pfizer, Inc.- Prostin VR pediatric Injection available from Pfizer

Teva Pharmaceuticals
(1-800-545-8800)

Bedford
(1-800-562-4797)

Pfizer, Inc.
(1-800-533-4535)

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%

9/18/2008

Ucyclyd Pharma, Inc. 1-888-829-2593, or 1-800-900-6389 with a representative available 24 hours, seven days a week.

See information in Related Information section.

Limited supplies continue to be available.

Please see attached DHP letter for important safety information.

Dear Healthcare Professional PDF document

Cisplatin Injection 1mg/ml

12/24/2008

APP Pharmaceuticals (888-386-1300)

Teva Pharmaceuticals
(1-800-545-8800)

Bedford (1-800-562-4797)

See information in Related Information section.

APP has supplies available and is currently allocating (50 mL vial -NDC 63323-103-51, 100 mL vial -NDC 63323-103-65, and 200 mL - NDC 63323-103-64).

Teva has their 50 mL vial (NDC 00703-5747-01) and 100 mL vial (NDC 00703-5748-11) on back order with expected releases in the next several weeks.

Bedford has all presentations, including Novaplus presentations, on backorder with no release date.

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. PDF document

Recall information from B. Braun. PDF document

Heparin sodium injection products remain available from these suppliers:

APP: 888-386-1300
additional APP ordering information PDF document

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

Leucovorin

11/20/2008

Teva Parenteral Medicines, Inc.
Leucovorin Calcium Lyophilized Powder for Injection, Preservative Free, Teva

Bedford Laboratories
Leucovorin Calcium Solution for Injection.

Leucovorin Calcium Lyophilized Powder for Injection, Preservative Free, Bedford

Manufacturing Delays

Please call 1-888-TevaUSA for additional information.

Bedford Customer Service 1-440-232-3320

Levoleucovorin (Fusilev) 50 mg single use vials.

11/20/2008

Spectrum Pharmaceuticals

1-877-387-4538 or 1-877-FUSILEV

See information in Related Information section.

Limited supplies continue to be available.

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 PDF document

Neupro Physician Information PDF document

Phospholine Iodide, Ophthalmic solution 0.125%

8/11/2008 updated

Wyeth Manufacturing delays

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

Dear Health Care Provider Letter PDF document

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

updated 10/9/2008

Mallinckrodt Inc. 888-744-1414

 
see "Related Information"

Updated Letter from Mallinckrodt PDF document

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.

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Resolved Drug Shortages

Drug Name Company Information Related Information

Albuterol Metered Dose Inhalers

Levalbuterol Metered Dose Inhalers

1/13/2009

Schering Plough- Proventil HFA (1-877-HFA-7768)

GlaxoSmithKline- Ventolin HFA (1-888-825-5249)

IVAX Laboratories, Inc- ProAir HFA (1-888-482-9522)

Sepracor- Xopenex HFA (levalbuterol tartrate) (1-888-394-7377)

The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand.

Additional information on CFC and MDIs

A-methapred (methylprednisolone sodium succinate) for injection 125mg and 40mg

1/24/2008

Hospira
877-946-7747

No further supply issues are anticipated.

Argatroban Injection

updated 11/18/2008

GlaxoSmithKline Response Center
888-825-5249

Routine supply has been re-established

BiCNU (carmustine) Injection

4/2/2008

Bristol-Myers Squibb
800-631-5244

No further supply issues are anticipated.

Letter from Bristol-Myers Squibb PDF

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.

Digoxin oral tablets

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

Fentanyl transdermal patch

11/12/2008

See Related Information section

Market continues to be supplied by the following firms:
Mylan: 800-796-9526
Pricara: 800-526-7736
Sandoz: 800-525-8747
Watson: 973-355-8300

Leukine (sargramostim) liquid 500 mcg vial

5/29/2008

Berlex Laboratories (Announcement from Bayer HealthCare Pharmaceuticals) Dear Healthcare Professional Letter PDF document

Lymphazurin 1% injection (isosulfan blue)

4/28/2008

Covidien (formerly U.S. Surgical)
1-203-845-1000

Covidien now has Lymphazurin 1% injection available.

Methadone Hydrochloride Injection

12/3/2008

Xanodyne Pharmaceuticals, Inc.

No further supply issues are anticipated

MVI Adult Injectable

12/4/2008

Hospira
877-946-7747

No further supply issues are anticipated

Proglycem (diazoxide) oral suspension

10/22/2008

Teva Pharmaceuticals 1-888-TevaUSA

No further supply issues are anticipated

Tikosyn (0.5mg and 0.25mg capsules) Pfizer Inc.
800-438-1985
Dear Healthcare Professional Letter PDF document

Vinblastine Sulfate Injection

11/13/2008

APP Pharmaceuticals 
1-888-386-1300

Bedford
1-800-562-4797
APP now has product available with normal expiration dating and is releasing vinblastine injection through regular distribution

Zanosar (Streptozocin) 1gm/vial Injection

9/26/2008
 
Teva Parenteral Medicines, Inc.

Please call 1-888-TevaUSA for additional information.


 

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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 PDF document (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 PDF document
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). Other cefotetan injection products continue to be available.

Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic  suspension)

6/5/2008

King Pharmaceuticals
800-776-3637

Letter from King Pharmaceuticals PDF document 

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 PDF document 
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 PDF document

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 PDF document

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 PDF document

Ethmozine (moricizine hydrochloride) 200mg, 250g, and 300mg tablets

9/17/2007

Shire US Inc.
725 Chesterbrook Blvd.
Wayne, Pa 19087
1-800-828-2088

Dear Healthcare Professional Letter PDF document

Exubera (insulin recombinant human, powder for inhalation)

10/19/2007

Pfizer
800-398-2372

Dear Healthcare Provider Letter PDF document

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 PDF document
Flovent Rotadisk (fluticasone propionate inhalation powder)

8/31/2004

GlaxoSmithKline
888-825-5249
Please see Dear Healthcare Professional letter PDF document 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 LetterPDF document
 

Foscavir (foscarnet sodium) injection

10/31/2008

AstraZeneca Pharmaceuticals LP (AstraZeneca)

Contact Corporate Information Center at 1-800-236-9933

The remaining inventory of Foscavir (foscarnet sodium) injection will be depleted by April 30, 2009. AstraZeneca has no further plans to manufacture or distribute Foscavir (foscarnet sodium) injection after April 30, 2009.

 

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

8/5/2008

EMD Serono
1-888-398-4567

EMD Serono has made a business decision to discontinue this product.

Dear Healthcare Professional Letter PDF document

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 PDF document

Humulin U ULTRALENTE (HUMAN INSULIN [rDNA ORIGIN] EXTENDED ZINC SUSPENSION)

7/6/2005

Eli Lilly and Company Dear Doctor Letter PDF document

Patient Information PDF document

Humulin L LENTE (HUMAN INSULIN [rDNA ORIGIN] ZINC SUSPENSION)

7/6/2005

 Eli Lilly and Company Dear Doctor Letter PDF document

Patient Information PDF document

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 PDF document

Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)

6/2/2008

King Pharmaceuticals
800-776-3637
Letter from King Pharmaceuticals. PDF document
Inulin in Sodium Chloride Injection, USP

9/26/2003
 

Questcor Pharmaceuticals, Inc. Letter PDF document
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 PDF document 

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 PDF
Mandol (cefamandole) all presentations

2/28/2003

Eli Lilly and Company Letter
Mitozytrex (Mitomycin for Injection)

9/12/2008

SuperGen

(925) 560-0100

Other Mitomycin approved products continue to be available.

This product was never commercialized.


 

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 PDF document

Nimotop (nimodipine) capsules

10/31/2008

Bayer HealthCare Pharmaceuticals
888-842-2937

Generic nimodipine remains available.

Please see Dear Healthcare Professional Letter PDF document for additional information.

 

Nolvadex (tamoxifen citrate)

4/10/2006
 

AstraZeneca
800-236-9933
Letter PDF document

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

5/17/2006

McNeil Consumer and Specialty Pharmaceuticals
888-440-7903
Other pancrelipase products continue to be available

Dear Health Care Provider Letter PDF document

 

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 PDF document

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 PDF document

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

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 PDF document
SecreFlo (porcine secretin for injection, 16 mcg/vial)

10/1/2008

ChiRhoClin, Inc., 1-877-272-4888
Please see Dear Healthcare Professional Letter PDF document for additional information.
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 PDF document

Sporanox (itraconazole) Injection

10/11/2007

Ortho Biotech Please see Dear Health Care Professional letter PDF document 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 PDF document

Tequin (gatifloxacin) Tablets and Injection

5/12/2006

Bristol-Meyers Squibb
 
See attached letter. PDF document

Tilade Inhaler (nedocromil sodium inhalation aerosol)

5/2/2008

King Pharmaceuticals
800-776-3637
Dear Healthcare Professional Letter PDF document(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 PDF document
Videx (didanosine) chewable/dispersable buffered tablets

9/19/2006

BMS Dear Healthcare Professional Letter PDF document
 
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 PDF document

Zyflo (zileuton) tablets

2/20/2008

Critical Therapeutics, Inc.

Zyflo CR continues to be available.

Dear Healthcare Professional Letter PDF document

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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 PDF Drug Shortage Management

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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. 

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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) 796-3400

 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.  

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 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 email us at drugshortages@fda.hhs.gov with feedback about this site.

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Last Updated: January 13, 2009

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