A drug receives Resolved status when the Drug Shortages Staff DSS determines that the market is covered, based on information from all manufacturers. The market is considered covered when supply is available from at least one manufacturer to cover total market demand. However, some manufacturers may not have all presentations available. DSS monitors the supply of products with Resolved status. For the most current supply information, contact the manufacturers. These drugs include those that are life-supporting, life-sustaining or for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. The discontinuations listed on the site reflect information received from manufacturers and are for informational purposes only.
Program participants are U. Current testing focuses on military-significant or contingency use products, drugs that have limited commercial use e. In addition to SLEP, there are other ways that, when appropriate, FDA can allow certain medical products to be used beyond their manufacturer-labeled expiration dates. This authority is limited to medical products for CBRN emergencies. In addition to the identification of specific lots, batches, or other units covered and the duration of the extension, FDA can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, and labeling.
If appropriate, FDA can also choose to not take enforcement action with respect to products that are held or used beyond their labeled expiration date. FDA acknowledges the stockpiling challenges of federal and SLTT stakeholders for example, related to doxycycline, ciprofloxacin, Tamiflu, and certain auto-injector products and remains committed to finding appropriate solutions to address such challenges.
To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number and original manufacture date. The letter noted that, based on FDA-approved supplemental New Drug Applications for Relenza inhalation powder and Tamiflu capsules that provided an expiration dating period of 7 years, it would be scientifically supportable for the expiry extension i.
FDA also recommended relabeling of such product prior to dispensing. More information. Expiration date extensions of certain lots of doxycycline hyclate. This document provides guidance to government stakeholders on testing to extend the shelf life i. This finalizes the draft guidance published on April 25, Federal Register notice Please contact Brad Leissa at brad. Also see: Expiration date extensions of certain lots of doxycycline hyclate.
April 25, FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non-emergency purpose.
Federal Register notice. Ceftazidime Fortaz Injection. Cefuroxime Sodium Zinacef Injection. Cetirizine Hydrochloride. Chlorothiazide Injection.
Chlorothiazide Tablets. Chlorpropamide Tablets. Ciprofloxacin Extended-Release Tablets.
FDA Drug Shortages
Clindamycin Injection, USP. Clomiphene Citrate. Clonazepam Tablets. Coumadin Tablets. Darifenacin Hydrobromide Tablets. Desloratadine Tablets. Dexmethylphenidate Hydrochloride Tablets. Dextroamphetamine Sulfate Extended-Release Capsules. Diclofenac Sodium Extended Release Tablets. Diclofenac Sodium Topical Gel.
SDA AND FDA UPDATES -- EXAM -- DATE EXTENDED NEWS 2020
Diclofenac Sodium Topical Solution. Diethylpropion Hydrochloride Controlled-Release Tablets. Diethylpropion Hydrochloride Tablets. Diltiazem Hydrochloride Extended-Release Capsules. Divalproex Sodium Extended-Release Tablets. Docetaxel Injection. Donepezil Hydrochloride Tablets. Doxorubicin Hydrochloride Injection. Doxycycline Capsules. Doxycycline Hyclate Capsules. Doxycycline Hyclate Delayed Release Tablets. Dronabinol Capsules. Dutasteride Capsules.
Entecavir Tablets. Epirubicin Hydrochloride Injection.
Eprosartan Mesylate Tablets. Eptifibatide Integrilin Injection. Ethinyl Estradiol and Levonorgestrel Myzilra. Ethinyl Estradiol; Norgestrel Tablets. Etomidate Amidate Injection. Fenofibric Acid Delayed-Release Capsules. Fentanyl Duragesic12, 25, 37, 50, 75 Extended-Release Film. Finasteride Tablets. Flumazenil Injection.
Fluorouracil Injection. Fluoxetine Capsules. Fluphenazine Hydrochloride Tablets. Flurbiprofen Tablets. Flutamide Capsules, USP. Fluvastatin Sodium Extended-Release Tablets. Gadopentetate Dimeglumine Magnevist Injection. Gemcitabine Hydrochloride Injection. Glimepiride Tablets. Glycopyrrolate Seebri Neohaler Inhalation Powder.
Guanfacine Hydrochloride Extended-Release Tablets. Hydrochlorothiazide Microzide Capsules.
Hydrochlorothiazide and Lisinopril Tablets. Hydrocortisone Acetate Suppository. Indomethacin Capsules. Ketoconazole Tablets. Lamivudine and Zidovudine Tablets.
Lamivudine Tablets. Lamotrigine Tablets.
Fda extended dating Antionette March 04, This on some lots of injectable drugs used by 4 months. To august to assist with the fda's drug administration fda has exercised its authorized archotelzeeland.com: Antionette. Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug Missing: extended dating. Aug 21, The Food and Drug Administration (FDA) has extended the expiration date of certain lots of Mylan's EpiPen (epinephrine) Auto-Injector mg by 4 months past the labeled date.
Lanoxin digoxin Tablets. Levocetirizine Dihydrochloride Tablets. Levofloxacin Tablets. Levoleucovorin Calcium Injection. Lidocaine HCl Topical Jelly. Liothyronine Sodium Tablets. Lisinopril Prinivil Tablets. Lisinopril Tablets. Meclizine Hydrochloride Tablets.
Medroxyprogesterone Acetate Provera Tablet. Megestrol Acetate Megace Oral Suspension. Mesna Injection. Metformin Hydrochloride Extended Release Tablets. Metformin Hydrochloride Tablets. Methocarbamol Tablet, USP. Methotrexate Tablets, USP. Methscopolamine Bromide Tablets. Methyclothiazide Tablets. Methylprednisolone Tablets. Metoprolol Tartrate Tablets. Mirtazapine Orally Disintegrating Tablets. Mirtazapine Tablets, USP. Modafinil Tablets.
Mometasone Furoate Elocon Topical Cream. Montelukast Sodium Tablets. Morphine Sulfate Extended-Release Tablets. Mupirocin Calcium Nasal Ointment. Mycophenolic Acid Delayed Release Tablets. Nafcillin Sodium Injection.
Naftifine Hydrochloride Cream. Naratriptan Hydrochloride Tablets. Nevirapine Extended Release Tablets.
73 rows Extended Use Dates Provided by Impax Generics to Assist with Epinephrine Auto . Jun 19, The U.S. Food and Drug Administration (FDA) has announced that a selection of the injectable drugs manufactured by Hospira, Inc., a Pfizer company, may be used passed the labeled expiration date to ease the ongoing critical shortage of critical care injectable drugs, including atropine, epinephrine and dextrose. More information on the specific. FDA supports a public health program involving other partners to extend the expiration dates for a limited number of carefully selected drug products.
Nystatin Cream, USP. Ocriplasmin Jetrea Injection. Olaratumab Lartruvo Injection. Olmesartan Medoxomil and Hydrochlorothiazide Tablets. Olopatadine Hydrochloride Pataday Ophthalmic Solution. Ombitasvir; Paritaprevir; Ritonavir Technivie Tablets.
OmegaAcid Ethyl Esters. Omeprazole Delayed-Release 40 mg Capsules. Oxybutynin Chloride Extended-Release Tablets. Oxycodone Hydrochloride Tablets.
Oxymorphone Hydrochloride. Paclitaxel Injection, USP. Peginterferon alfa-2b Sylatron. Penicillin V Potassium Tablets. Pentoxifylline Extended-Release Tablets.
U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD INFO-FDA Contact FDAMissing: extended dating. rows This is to ate and consolidate the extended use date information posted previously (6/15/17 to present). Due to continued intermittent supply interruptions of critical drugs, FDA .
Phenobarbital Oral Solution. Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets. Pramipexole Dihydrochloride Extended Release Tablets. Primidone Tablets, USP.
Prinivil Tablets. Promethazine Hydrochloride Injection, Solution. Promethazine Suppository. Pyrazinamide Tablets, USP. Quinapril Hydrochloride Accupril Tablets. Quinidine Gluconate Injection. Rabeprazole Sodium Delayed-Release Tablets. Ranitidine Injection, USP. Repaglinide Tablets. Ribavirin Rebetol Oral Solution. Ribavirin Capsules and Tablets. Risedronate Sodium Tablets. Risedronate Tablets. Risperidone Tablets. Rivastigmine Tartrate Capsules. Rizatriptan Benzoate Orally Disintegrating Tablets.
Saquinavir Mesylate Invirase mg Capsules.
Simeprevir Capsules. Simvastatin Zocor Tablets. Sotalol Hydrochloride Tablets. Spironolactone Tablets. Spironolactone Tablets, USP. Stavudine Capsules. Sumatriptan Sumavel DosePro Injection. Sumatriptan Succinate Imitrex Injection. Sumatriptan Succinate Injection. Telmisartan and Amlodipine Twynsta Tablets.
Temozolomide Capsules. Testosterone Buccal System. Testosterone Topical Gel.
Tizanidine Hydrochloride Tablets. Tolazamide Tablets. Tolbutamide Tablets. Tositumomab and Iodine I Tositumomab Bexxar. Tramadol Hydrochloride Ultram Tablets. Trandolapril Tablets. Tranexamic Acid Tablets. Trazodone Tablets.
Triamcinolone Acetonide Cream. Triamterene and Hydrochlorothiazide Dyazide Capsules. Triamterene and Hydrochlorothiazide Tablets. Valacyclovir Hydrochloride Tablets. Vardenafil Hydrochloride Levitra Tablets. Verapamil Hydrochloride Tablets.
Fda extended dating
Vinorelbine Tartrate Injection. Zoledronic Acid Injection.
Zolpidem Tartrate Extended Release Tablets.