Drugs
>> Wednesday, 27 January 2010
Drugs to be Discontinued
| 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
| 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). Other cefotetan injection products continue to be available. |
| Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) 6/5/2008 | King Pharmaceuticals800-776-3637 | Letter from King Pharmaceuticals |
| Cortisporin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) 6/5/2008 | King Pharmaceuticals800-776-3637 | 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 |
| Cytoxan (cyclophosphamide) 25mg and 50mg tablets 9/24/2007 | Bristol-Myers Squibb Company609-897-2412 | 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 Company609-897-2412 | Alternate products continue to be available from other companies. |
| 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. |
| Emergency Syringes
12/08/2009 | Amphastar/IMS | List of Products to Be Discontinued by Amphastar/IMS (PDF - 15KB) These emergency syringes remain available in similar presentations from Hospira. Hospira Customer Care may be contacted at |
| 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 | Pfizer800-398-2372 | 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... | Dear Healthcare Provider Letter |
| Flovent Rotadisk (fluticasone propionate inhalation powder) 8/31/2004 | GlaxoSmithKline888-825-5249 | 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. |
| 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 Serono1-888-398-4567 | EMD Serono has made a business decision to discontinue this product. |
| Humatin (Paromomycin Sulfate Capsules, USP)
2/7/2008 | King Pharmaceuticals Professional Information Services Department800-776-3637 | King Pharmaceuticals has made a decision to discontinue Humatin (Paromomycin Sulfate Capsules, USP) Paromomycin continues to be available from another manufacture.
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| Humulin 50/50 Insulin updated
| Eli Lilly and Company1-800-545-5979 | |
| Humulin U ULTRALENTE (HUMAN INSULIN [rDNA ORIGIN] EXTENDED ZINC SUSPENSION) 7/6/2005 | Eli Lilly and Company | |
| Humulin L LENTE (HUMAN INSULIN [rDNA ORIGIN] ZINC SUSPENSION) 7/6/2005 | Eli Lilly and Company |
|
| HIVID (zalcitabine) tablets 7/26/2006 | Roche Pharmaceuticals | The sale and distribution of its anti-HIV |
| 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 Pharmaceuticals800-776-3637 | 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 Pharmaceuticals800-776-3637 | 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
| 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
| 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 1-8... for additional information. |
| Moban (molindone hydrochloride) 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 Pharmaceuticals888-842-2937 | Generic nimodipine remains available.
|
| Nolvadex (tamoxifen citrate) 4/10/2006 | AstraZeneca800-236-9933 | Letter |
| Novolin InnoLet disposable pens and Novolin PenFill 3 mL cartridges for Novolin R, N and 70/30 8/13/2009 | Novo Nordisk1-800-727-6500 | Dear Healthcare Provider Letter Dear Patient Letter |
| Novolin L, Lente, human insulin zinc suspension [rDNA origin] 7/15/2003
| Novo Nordisk Pharmaceuticals, Inc. Contact:
| 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 Pharmaceuticals888-440-7903 | Other pancrelipase products continue to be available |
| 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. |
| Procanbid (Procanamide Hydrochloride Extended-Release Tablets) 11/9/2007 | King Pharmaceuticals 800-776-3637 | Dear Prescriber Letter |
| 5/2/2007 | Abbott 200 Abbott Park Road Abbott Park, IL 60064-6157 Customer Service: 800... | 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 Corporation888-229-0001 | 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 | GlaxoSmithKline800-340-3236 | GSK anticipates that SEREVENT Inhalation Aerosol will no longer be available starting in June 2003. |
| 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 | GlaxoSmithKline888-825-5249 | 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 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 |
| Tenormin (atenolol) 0.5mg/ml Injection 2/28/2008 | AstraZeneca Pharmaceuticals LP (AstraZeneca) – Contact Corporate Information Center:800... | 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 Squibb609-897-2412 | Bristol-Myers Squibb Company has made a decision to discontinue Teslac (testolactone tablets, USP) 50mg tablets. |
| Tequin (gatifloxacin) Tablets and Injection 5/12/2006 | Bristol-Meyers Squibb | See attached letter |
| Tilade Inhaler (nedocromil sodium inhalation aerosol) 5/2/2008 | King Pharmaceuticals800-776-3637 | 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: 800-727-6500Customer 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 | AstraZeneca800-842-9920 | 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 Roche | Please 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. |
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