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Drugs to be Discontinued: Original Prefilled Pen that Contains Humalog, Humalog Mix 75/25, and Humalog Mix 50/50

Posted Sep 14 2010 8:26am
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 NameCompany InformationRelated 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 CorporationBaxter 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). 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  

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.

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

Exubera (insulin recombinant human, powder for inhalation)

10/19/2007

Pfizer
800-398-2372
Dear Healthcare Provider Letter

Faslodex * (fulvestrant) Injection, 2.5 ml (2 x 2.5 ml pre-filled syringe), (125 mg /2.5 ml (50 mg/ml) FASLODEX intramuscular injection), NDC 0310-0720-2510

11/2/2009

AstraZeneca Pharmaceuticals LP (AstraZeneca)-Contact the Corporate Communication Center at 1-800-236-9933

There is no remaining inventory within AstraZeneca's distribution network. The final expiration date of any Faslodex* (fulvestrant) Injection that may still be remaining in the market place is December 31, 2010. 

(The supply of the single 5.0 ml syringe [250 mg/5 ml (50 mg/ml)] Faslodex pack, NDC 0310-0720-50, is not affected, and is currently available.)

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
 

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

PfizerPfizer 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
 

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 50/50 Insulin
 

updated
12/2/2009

Eli Lilly and Company
1-800-545-5979

Dear Healthcare Professional Letter (PDF - 201KB)

Patient Information (PDF - 887KB)

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 Inhaler (cromolyn sodium inhalation aerosol)

8/3/2009

King Pharmaceuticals Dear Healthcare Professional Letter

Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)

6/2/2008

King Pharmaceuticals
800-776-3637
Letter from King Pharmaceuticals

Inversine (mecamylamine hydrochloride) Tablets, 2.5 mg

6/17/2009

Targacept, Inc.
336-480-2100
Dear Healthcare 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

Kemadrin (procyclidine hydrochloride)

6/6/2008

King Pharmaceuticals
800-776-3637
Letter from King Pharmaceuticals  

Lanoxin Elixir(digoxin)

6/3/2005

GlaxoSmithKlineThis 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

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 LaboratoriesAlternative products that can be used in place of Mivacron continue to be available. Please call Abbott at 1-800-633-9110 for additional information.

 

Moban (molindone hydrochloride)
5 mg, 10 mg, 25 mg, and 50 mg Tablets

1/13/2010

Endo Pharmaceuticals Inc.
1-800-462-ENDO (1-800-462-3636)
Moban tablets have been discontinued and supplies are anticipated to be depleted by June 30, 2010.

Nandrolone Decanoate Injection

6/24/2009

Watson Pharmaceuticals
(800) 272-5525
Watson Pharmaceuticals has discontinued this product because of the unavailability of the active pharmaceutical ingredient.

Neutrexin (trimetrexate glucuronate) Injection

6/14/2007

MedImmune, Inc. Dear Healthcare Professional Letter

Nimotop (nimodipine) capsules

10/31/2008

Bayer HealthCare Pharmaceuticals
888-842-2937

Generic nimodipine remains available.

Please see Dear Healthcare Professional Letter  for additional information.
 

Nolvadex (tamoxifen citrate)

4/10/2006
 

AstraZeneca
800-236-9933
Letter

Novolin InnoLet disposable pens and Novolin PenFill 3 mL cartridges for Novolin R, N and 70/30

8/13/2009

Novo Nordisk
1-800-727-6500
Dear Healthcare Provider Letter

Dear Patient 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

Original Prefilled Pen that Contains Humalog, Humalog Mix 75/25, and Humalog Mix 50/50

New!
9/14/2010

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

 

Perchloracap (potassium perchlorate) 200 mg capsules

6/2/2005

Tyco HealthcarePerchloracap capsules have been discontinued and supplies are anticipated to be depleted by the end of 2005.

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

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

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

10/1/2008

ChiRhoClin, Inc., 1-877-272-4888
 
Please see Dear Healthcare Professional Letter 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

Sporanox (itraconazole) Injection

10/11/2007

Ortho BiotechPlease 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

Vesanoid (tretinoin) Soft Gelatin Capsule 10 mg

12/17/2009

Hoffmann-La Roche Inc

Please see the Dear Customer Letter titled: Vesanoid 10mg (tretinoin) Product Deletion at: Vesanoid

Teva is increasing supply of their tretinoin 10mg capsules to meet market demand (NDC 00555-0808-02).

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
 

Zenapax (daclizumab) sterile Concentrate for Injection

12/18/2009

Hoffman-La RochePlease see Dear Healthcare Professional Letter for additional information

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

    
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