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What's New by Date
This page
lists new and
revised documents posted to the CDER web site.
Each listing will remain on this page approximately 30 days. The dates
listed indicate the dates of posting to the CDER web site, not the dates of
origination or revision. When viewing a document, click your browser's
"refresh" or "reload" button to make sure you are
seeing the latest version.
November 17, 2004
November 16, 2004
November 15, 2004
- FDA announces important labeling changes for Mifeprex (mifepristone,
also known as RU-486).
Mifeprex
Information.
-
New and Generic Drug Approvals
-
Citalopram Hydrobromide Tablets, Caraco Pharma,
Approval
-
Omacor
(Omega-3-Acid Ethyl Esters) Capsules, Abbott, Approval
-
Paclitaxel Injection, SuperGen,
Inc., Approval
-
Sotradecol (Sodium Tetradecyl Sulfate) Injection, Bioniche Pharma,
Approval
- Pediatric Exclusivity Labeling Changes (updated)
- Prescription Drug User Fee Act (updated)
- The FY 2004 "cleanup" invoices were mailed out November 15, 2004. The
payments are due to FDA by December 15, 2004. If you didn't get an invoice,
and you have a new product or establishment approved during FY 2004, please
contact the user fee staff.
- The phone number to obtain a UFID number for CDER applications and
supplements has been changed. Please call 301-210-2880 for assignment of a
UFID number.
- Warning Letters and Notice of Violation
Letters to Pharmaceutical Companies
November 12, 2004
- Drug Shortage:
Current; Methotrexate Injection
- FDA approves first-time generic Sotradecol Injection (Sodium Tetradecyl Sulfate
Injection) for the treatment of small uncomplicated varicose veins
of the lower extremities. The reference listed drug is Sotradecol
Injection.
November 10, 2004
-
CDER Key Officials
-
Drug Approval Reports
-
New and Generic Drug Approvals
-
Augmentin ES-600 (amoxicillin/clavulanate
potassium) Oral Suspension, GlaxoSmithKline, Labeling Revision
-
Delsym (dextromethorphan polistirex) Extended-Release Suspension, Celltech Pharma,
Formulation Revision
-
Humulin
70/30 Injection, Eli Lilly, Labeling Revision
-
MIOSTAT (carbachol intraocular solution), Alcon,
Labeling Revision
-
Naprosyn (naproxen) Tablets, Roche
Palo Alto, Labeling Revision
-
Anaprox/Anaprox DS (naproxen sodium) Tablets, Roche
Palo Alto, Labeling Revision
-
Naprosyn (naproxen) Suspension, Roche
Palo Alto, Labeling Revision
-
EC-Naprosyn (naproxen) Delayed Release Tablets, Roche
Palo Alto, Labeling Revision
-
Omacor
(omega-3-acid ethyl esters) Capsules, Ross Products, Approval
- BPCA/Pediatric Exclusivity Statistics
- Vioxx (rofecoxib): Slide Presentation by Sandra Kweder, M.D., November 10, 2004.
[HTML] [PowerPoint]
November 9, 2004
November 8, 2004
- FDA and Abbott Pharmaceuticals notify healthcare professionals of revisions to
the WARNINGS section of the prescribing information for Humira (adalimumab),
indicated for the treatment of rheumatoid arthritis.
MedWatch Safety Info.
-
New and Generic Drug Approvals
-
Canasa (Mesalamine, USP) Rectal Suppositories, Axcan Scandipharm,
New Dosage Regimen
-
Citalopram Hydrobromide
Tablets, Alphapharm, Approval
-
Citalopram Hydrobromide
Tablets, Watson Labs, Approval
-
Citalopram Hydrobromide Tablets, Kali
Labs, Approval
-
Phenergan (promethazine HCl) Suppositories, Wyeth Pharma,
Labeling Revision
-
Phenergan (promethazine HCl) Suppositories, Wyeth Pharma,
Labeling Revision
-
Phenergan (promethazine HCl) Suppositories, Wyeth Pharma,
Labeling Revision
-
Robinul (glycopyrrolate for injection, USP)
Injection, Baxter Healthcare, Labeling Revision
-
Striant (testosterone buccal system) mucoadhesive,
Columbia Lab, Control Supplement
-
Trecator (ethionamide tablets, USP) Tablets, Wyeth Pharma,
Manufacturing Change or Addition & Formulation Revision
-
Tricor (fenofibrate)
Tablets, Abbott, Approval
November 5, 2004
November 4, 2004
-
New and Generic Drug Approvals
-
LEVAQUIN (levofloxacin) Tablets, Ortho McNeil Pharma,
Labeling Revision
-
LEVAQUIN (levofloxacin) Injection, Ortho McNeil Pharma,
Labeling Revision
-
Orvaten (Midodrine Hydrochloride) Tablets, Upsher-Smith
Labs, Approval
-
Pioglitazone Hydrochloride Tablets, Mylan Pharma,
Tentative Approval
-
Soriatane (acitretin) Capsules, Connetics
Corp., Labeling Revision
-
Topiramate Tablets, Teva Pharma, Tentative Approval 076317
-
Tylenol Arthritis Pain Extended release tablets, McNeil
Consumer, Package Change
-
ZYBAN (bupropion
hydrochloride), GlaxoSmithKline, Labeling Revision
November 3, 2004
-
Guidance Documents
-
New and Generic Drug Approvals
-
Cordarone (amiodarone HCl) Tablets, Wyeth Pharma,
Labeling Revision
-
Cordarone (amiodarone HCl) Intravenous, Wyeth Pharma,
Labeling Revision
-
Felodipine Extended-Release Tablets, Mutual Pharma,
Approval
-
Loxapine Capsules, Mylan Pharma,
Approval
-
Megestrol
Acetate Oral Suspension, Morton Grove, Approval
-
Norditropin Cartridges (somatropin [rDNA origin]) injection, Novo Nordisk,
New or Modified Indication
-
Restoril (temazepam) Capsules, Mallinckrodt
Inc., Manufacturing Change or Addition
-
Saizen (somatropin [rDNA origin]) Injection, Serono,
Inc., New or Modified Indication
-
Today (1 gram nonoxynol- 9 vaginal contraceptive) Sponge, Allendale
Pharmaceuticals, Labeling Revision
-
The FDA has written a
proposed Medication Guide about Using Antidepressants in Children or
Teenagers and sent this Medication Guide to all the sponsors on October
21, 2004. To inform other groups and individuals with an interest in this
Medication Guide, it has also been linked to the
Antidepressants web page. The
FDA hopes to finalize the language of this Medication Guide by December 2004
so that the Medication Guide can be produced and made available to patients
by the end of January 2005.
November 2, 2004
November 1, 2004
October 29, 2004
-
Approved Active Moieties to
Which FDA has Granted Pediatric Exclusivity for Pediatric
Studies under Section 505A of the Federal Food, Drug, and
Cosmetic Act (updated)
-
Drug Shortage:
Resolved; Amphadase (hyaluronidase)
injection, USP, 150 IU mL
- FDA approves five first-time generics for Citalopram
Hydrobromide Tablets, 10 mg (base), 20 mg (base) and 40 mg (base)
to treat depression. The reference listed drug is Celexa.
-
New and Generic Drug Approvals
-
Bethanechol Chloride Tablets, Amide Pharma,
Approval
-
Bethanechol Chloride Tablets, Amide Pharma,
Approval
-
Bethanechol Chloride Tablets, Amide Pharma,
Approval
-
Bethanechol Chloride Tablets, Amide Pharma,
Approval
-
Carboplatin Injection, Mayne Pharma,
Approval
-
Cenestin (synthetic conjugated estrogens, A) Tablets, Duramed Pharma,
Labeling Revision
-
Citalopram Hydrobromide
Tablets, Eon Labs, Approval
-
Citalopram Hydrobromide Tablets, Dr. Reddy’s
Labs, Approval
-
Citalopram Hydrobromide Tablets, CorePharma,
Approval
-
Citalopram Hydrobromide Tablets, Aurobindo Pharma,
Approval
-
Citalopram Hydrobromide Tablets, Purepac Pharma,
Approval
-
Claritin (loratadine) Syrup, Schering
Corp., Control Supplement
-
Doxil (doxorubicin HCl liposome) injection, Johnson & Johnson Pharma,
Efficacy Supplement with Clinical Data to Support
-
Enalapril Maleate & Hydrochlorothiazide Tablets, Apotex,
Approval
-
Lithium
Carbonate Extended-Release Tablets, Roxane Labs, Approval
-
Pepcid AC Film Coated (famotidine)
Tablets, Merck Research, Labeling Revision
-
Pepcid AC Chewable (famotidine)
Tablets, Merck Research, Labeling Revision
-
Pepcid AC Gelcaps (famotidine)
Capsules, Merck Research, Labeling Revision
-
Pepcid
Complete Tablets, Merck Research, Labeling Revision
-
Protonix I.V. (pantoprazole) Injection, Wyeth Pharma,
Control Supplement
-
Sodium Chloride Injection, Haemonetics
Corp., Approval
-
Testosterone Gel,
Paddock Labs, Tentative Approval
-
Wellbutrin XL (bupropion
hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
- Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on
Dosing and Labeling [HTML] or [Word] or [PDF]
October 28, 2004
October 27, 2004
-
New and Generic Drug Approvals
-
Amphadase (hyaluronidase injection, USP), Amphastar Pharma,
Approval
-
Axid AR (nizatidine) Tablets, Wyeth
Consumer, Labeling Revision
-
Cuprimine (penicillamine)
Capsules, Merck & Co., Inc., Labeling Revision
-
Finasteride Tablets, Teva
Pharmaceuticals, Tentative Approval
-
FOSRENOL (lanthanum carbonate) Chewable Tablets, Shire Pharma,
Approval
-
Keppra (levetiracetam) Tablets, UCB Pharma,
Inc., Labeling Revision
-
Keppra (levetiracetam) Oral Solution, UCB Pharma,
Inc., Labeling Revision
-
(Lidocaine HCl 2% and Epinephrine 1:100,000 Solution for Topical Iontophoretic System), Empi,
Inc., Approval
-
Medroxyprogesterone Acetate Injectable Suspension, Sicor Pharma,
Approval
October 26, 2004
- FDA, Janssen Pharmaceutica Products, and Johnson & Johnson
Pharmaceutical Research & Development notify healthcare
professionals of reports of medication errors involving confusion
between Reminyl and Amaryl (glimepiride).
MedWatch Safety Info.
-
Inactive Ingredient Database
October 25, 2004
-
Drug Approval Reports
-
New and Generic Drug Approvals
-
Carvedilol
Tablet, Ranbaxy, Tentative Approval
-
Diruil
(chlorothiazide) intravenous Injection and tablets, Merck & Co., Labeling
Revision
-
Evoclin (clindamycin phosphate) Foam, Connetics
Corp, Approval
-
InnoPran XL (propranolol
hydrochloride) Extended Release Capsules, Reliant, Labeling Revision
-
Mirtazapine Tablets, Aurobindo Pharma,
Approval
-
Sustiva (efavirenz)
tablets, Bristol-Myers Squibb, Labeling Revision
-
Sustiva (efavirenz)
capsules, Bristol-Myers Squibb, Labeling Revision
-
Tikosyn (dofetilide)
Capsules, Pfizer Inc., Labeling Revision
-
Xenical (Orlistat) Capsules, Hoffman-LaRoche,
Efficacy Supplement with Clinical Data to Support
October 22, 2004
-
New and Generic Drug Approvals
-
Betimol (timolol
ophthalmic solution), Santen, Labeling Revision
-
Carboplatin
Injection, American Pharmaceutical, Approval
-
Concerta (methylphenidate HCL) Extended-Release Tablets, McNeil,
New or Modified Indication
-
Gabapentin Tablets, Purepac Pharma,
Approval
-
Habitrol (nicotine transdermal system), Novartis,
Package Change
-
Levaquin (Levofloxacin)
Oral Solution, J & J Pharmaceuticals, Approval
-
PROPECIA (finasteride)
Tablets, Merck & Co., Labeling Revision
- Orange Book: Query
-
Orange Book: Cumulative Supplement No
9
- Orange Book: Information and Data Files
- Orange Book: Monthly Additions and
Deletions
October 21, 2004
October 20, 2004
-
New and Generic Drug Approvals
-
Allegra-D 24 Hour Extended-Release Tablets, Aventis Pharma,
Approval
-
KALETRA (Lopinavir/Ritonavir) capsules, Global Pharma,
Efficacy Supplement with Clinical Data to Support
-
KALETRA (Lopinavir/Ritonavir) oral solution, Global Pharma,
Efficacy Supplement with Clinical Data to Support
-
Metolazone Tablets, Mylan Pharma,
Chemistry New Strength
-
Torsemide Tablets, Pliva Pharma,
Chemistry New Strength
October 19, 2004
-
New and Generic Drug Approvals
-
Alocril (nedocromil sodium ophthalmic solution), Allergan,
Package Change & Labeling Revision
-
Aricept (donepezil HCl)
Oral Solution, Eisai Medical Research, Approval
-
Aricept (donepezil HCl)
Orally Disintegrating Tablet, Eisai Medical Research, Approval
-
Cefazolin Injection, Hikma Farmaceutica,
Approval
-
Cefuroxime Axetil Tablets, Teva Pharma,
Approval
-
Gabapentin
Capsules, Watson Labs, Tentative Approval
-
LUPRON (leuprolide acetate) Injection, TAP Pharma,
Labeling Revision
October 18, 2004
-
FDA/ISPE Forum on New PAT Guidance, November 16, 2004, Arlington, VA
(international locations also available)
Meeting Information
-
Manual of Policies and Procedures (MaPP)
4601.3 Children in the Workplace
-
New and Generic Drug Approvals
-
Altace (ramipril) Capsules, King Pharma,
Labeling Revision
-
Carboplatin
Injection, Bedford Labs, Approval
-
Fosinopril Sodium Tablets, Andrx Pharma,
Approval
-
Fuzeon (enfuvirtide) Injection, Hoffmann-La Roche,
Accelerated Approval
-
Levofloxacin Tablets,
Mylan Pharma,
Approval
-
Metformin Hydrochloride Extended-Release Tablets, Barr
Labs, Approval
-
Saizen (somatropin [rDNA origin]) Injection, Serono,
New or Modified Indication
-
Ultra-TechneKow DTE (Technetium Tc99m Generator), Mallinckrodt,
Control Supplement
-
Visine-A Eye Drop, Pfizer, Labeling Revision
- Office of Generic Drugs -
Statement on Expedited Review of Generic Drug Products for the
Prophylaxis and Treatment of Illness Caused by Various Strains of
the Influenza Virus.
October 15, 2004
- FDA today issued a Public Health Advisory
announcing a multi-pronged strategy to warn the public about the increased
risk of suicidal thoughts and behavior ("suicidality") in children
and adolescents being treated with antidepressant medications.
- Paragraph IV Patent Certifications (no
changes from 10/1/2004)
October 14, 2004
-
New and Generic Drug Approvals
-
Carboplatin
Injection, Bedford Labs, Approval
-
Carboplatin Injection, Mayne Pharma,
Approval
-
Carboplatin
Injection, Pharmachemie, Approval
-
Carboplatin
Injection, American Pharmaceutical Partners, Approval
-
Finasteride Tablets, Dr. Reddy’s
Labs, Tentative Approval
-
Metformin
Hydrochloride Extended-Release Tablets, Eon Labs, Tentative Approval
-
Sandostatin LAR Depot (octreotide acetate) Injection, Novartis Pharma,
Labeling Revision
-
Septocaine (articaine HCl 4% w/epinephrine 1:100,000) Injection, Deproco,
Inc., Labeling Revision
- FDA approves four
first-time generics for Carboplatin for initial and secondary treatment of advanced ovarian cancer. The reference listed drug is Paraplatin.
October 13, 2004
-
Cyber Warning Letters for
June and September, 2004
-
FDA and Centocor notify healthcare professionals of revisions to the
prescribing information for Remicade, indicated for the treatment of
rheumatoid arthritis and Crohn's disease. In controlled studies of all TNFα-blocking
agents, including Remicade, more cases of lymphoma have been observed among
patients receiving the agents than among control group patients.
MedWatch Safety Info.
-
New and Generic Drug Approvals
-
Imitrex (sumatriptan)
nasal spray, GlaxoSmithKline, Patient Population Altered
-
Norditropin Cartridges (somatropin rDNA origin) Injection, Novo Nordisk,
New or Modified Indication
-
Plavix (clopidogrel
bisulfate) Tablets, Sanofi-Synthelabo, Labeling Revision
October 12, 2004
-
New and Generic Drug Approvals
-
Betamethasone Dipropionate Ointment, Taro Pharma,
Approval
-
Fenoldopam Mesylate
Injection, Bedford Labs, Approval
-
Flumazenil Injection, American Pharma,
Approval
-
Flumazenil
Injection, Baxter HealthCare, Approval
-
Flumazenil
Injection, Bedford Labs, Approval
-
Flumazenil Injection, Apotex
Corp., Approval
-
Flumazenil Injection, Sicor Pharma,
Approval
-
Fosinopril Sodium Tablets, Sandoz
Inc., Approval
-
Hydrocodone Bitartrate and Ibuprofen Tablets, Interpharm,
Supplement
-
NovoLog (insulin aspart [rDNA origin] injection), Novo Nordisk,
Labeling Revision
-
NovoLog Mix 70/30, Novo Nordisk,
Labeling Revision
-
VANTAS (histrelin implant), Valera Pharma,
Approval
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