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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.
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, GlaxoSmithKline, Labeling Revision
-
Sustiva (efavirenz)
capsules, GlaxoSmithKline, 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
October 8, 2004
- Biogen Idec and Genentech notify healthcare professionals of
revisions to the prescribing section of the Rituxan (rituximab)
label due to reports of Hepatitis B virus (HBV) reactivation with
fulminant hepatitis, hepatic failure, and death in some patients
with hematologic malignancies.
MedWatch Safety Info.
-
Drug Master Files (updated)
- FDA approves first-time generic Gabapentin for adjunctive
therapy in the treatment of partial seizures with and without
secondary generalization in adults with epilepsy. The reference
listed drug is Neurontin.
- Investigational Human Drugs: Clinical Investigator
Inspection List (updated)
-
New and Generic Drug Approvals
-
Diflucan (fluconazole)
Tablets, Pfizer, Inc., Labeling Revision
-
Diflucan (fluconazole)
Injection, Pfizer, Inc., Labeling Revision
-
Diflucan (fluconazole)
Powder, Pfizer, Inc., Labeling Revision
-
Gabapentin Capsules, Teva Pharma,
Approval
-
Luveris 75 IU (lutropin alfa for injection), Serono,
Approval
-
SORIATANE (acitretin) Capsules, Connetics,
Labeling Revision
October 7, 2004
October 6, 2004
-
National Recruitment Efforts Underway for
Director of Oncology Drug Products in CDER’s Office of New Drugs
-
New and Generic Drug Approvals
-
Cetirizine Hydrochloride Tablet, Par Pharma,
Tentative Approval
-
Ciprofloxacin Tablets, Taro Pharma,
Approval/100mg Tentative Approval
-
Ketorolac Tromethamine Injection, Sabex
2002, Approval
-
Lisinopril and Hydrochlorothiazide Tablet, Apotex
Corp., Approval
-
REYATAZ (atazanavir)
tablets, Bristol-Myers Squibb, Labeling Revision
- Presentation:
Biopharmaceutics and Drug Product Quality: Performance Tests for
Drug Products, A Look Into the Future, Ajaz S. Hussain, Ph.D. CDER,
USP Annual Scientific Meeting, September, 2004. [PDF]
- Pediatric Drug Development
October 5, 2004
-
New and Generic Drug Approvals
-
Loratadine Syrup, Apotex
Corp., Approval
-
Nevis (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Barr
Labs, Tentative Approval
-
Prednisolone Sodium Phosphate Oral Solution, Morton Grove Pharma,
Approval
-
Vesanoid (tretinoin) Capsules, Hoffman-La Roche,
Labeling Revision
- Office of Generic Drugs (updated)
Public Meeting - Radioactive Drugs for Certain Research Uses.
November 16, 2004, Rockville, MD.
Meeting Information
October 4, 2004
-
Bioresearch Monitoring Information System File
(updated)
- FDA and King Pharmaceuticals notify healthcare professionals
of revisions to the Levoxyl labeling, describing reports of
choking, gagging, tablets stuck in throat and dysphagia while
taking Levoxyl.
MedWatch Safety Info.
-
New and Generic Drug Approvals
-
Metformin Hydrochloride Extended-Release Tablets, Purepac Pharma,
Tentative Approval
-
Monistat 1
Combination Pack, Personal Products Co., New Dosage Regimen
-
Ribavirin Capsules, Teva Pharma,
Approval
-
Terconazole Vaginal Cream, Altana
Inc., Approval
-
Paragraph IV Drug Product Applications
(updated)
October 1, 2004
-
New and Generic Drug Approvals
-
BSS (balanced salt solution) Sterile Irrigating Solution, Alcon
Laboratories, Labeling Revision
-
Mefloquine
Hydrochloride Tablets, Roxane Labs, Approval
-
Metformin Hydrochloride Extended-release Tablets, Purepac Pharma,
Approval
-
Monistat 1 Combination Pack, Personal Products, New Dosage Regimen
-
NeoTect (Kit for the Preparatio n of Technetium Tc99m Depreotide Injection), Berlex,
Formulation Revision
-
Norditropin NordiFlex (somatropin [rDNA origin] injection), Novo Nordisk,
Package Change
- Preparation for International Conference on Harmonization Meetings in
Yokohama, Japan October 19, 2004, Rockville, MD.
Meeting Information.
September 30, 2004
- CDER Organization Charts
-
Drug Shortage: Current; Merrem
I.V.(meropenem for injection)
- FDA issues a Public Health Advisory on Vioxx as its
manufacturer voluntarily recalls the product.
Vioxx Information.
-
New and Generic Drug Approvals
-
Cancidas (caspofungin
acetate) for Injection, Merck & Co., New or Modified Indication
-
Combivir (lamivudine/zidovudine)
tablets, GlaxoSmithKline, Labeling Revision
-
EPIVIR (lamivudine)
tablets, GlaxoSmithKline, Labeling Revision
-
EPIVIR (lamivudine)
oral solution, GlaxoSmithKline, Labeling Revision
-
Halog (halcinonide)
cream, Bristol-Myers Squibb, Labeling Revision
-
Halog Ointment (halcinonide),
Bristol-Myers Squibb, Labeling Revision
-
Halog (halcinonide)
Topical Solution, Bristol-Myers Squibb, Labeling Revision
-
Halog-E (halcinonide)
cream, Bristol-Myers Squibb, Labeling Revision
-
Metformin Hydrochloride Extended-Release Tablets, Andrx,
Tentative Approval
-
Norepinephrine Bitartrate
Injection, PharmaForce, Approval
-
Tizanidine Hydrochloride Tablets, Ivax Pharma,
Approval
- 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)
- Approved Active Moieties
for which FDA has Issued a Written Request for Pediatric Studies
under Section 3 of the
Best Pharmaceuticals for Children Act (updated)
September 29, 2004
- Draft Guidance for Industry and FDA Staff: Application User Fees for
Combination Products.
Federal Register notice [HTML]
or [TXT]
or [PDF]
Drug Shortage:
Resolved; Duragesic
(fentanyl transdermal system)
FDA issues the final report on its 21st Century Initiative on
the Regulation of Pharmaceutical Manufacturing.
FDA News. Final
Report.
New and Generic Drug Approvals
-
(Amlexanox) Mucoadhesive
Patch, Pharmaceuticals, Approval
-
Abilify (aripiprazole) Tablets, Otsuka
Maryland Research, New or Modified Indication
-
Advair Diskus (fluticasone propionate and salmeterol xinafoate
inhalation powder), GlaxoSmithKline, Labeling Revision
-
Aranelle (Norethindrone & Ethinyl Estradiol) Tablets, Barr
Laboratories, Approval
-
Caduet (amlodipine besylate/atorvastatin
calcium) Tablets, Pfizer Inc., Supplement
-
Cleocin HCl (clindamycin
hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
-
Cleocin Phosphate (clindamycin injection, USP)
Sterile Solution, Pfizer, Inc., Labeling Revision
-
Cleocin Phosphate (clindamycin
injection in 5% dextrose) IV Sterile Solution, Pfizer, Inc., Labeling Revision
-
Clorazepate Dipotassium
Tablets, Ranbaxy Labs, Approval
-
Dexrazoxane
Injection, Bedford Labs, Approval
-
Haloperidol Injection, Sabex
2002 Inc., Approval
-
Oxycodone Hydrochloride Extended-Release Tablet(80mg), Endo Pharma,
Approval
-
Pamidronate Disodium
Injection, Bedford Laboratories, Manufacturing Change or Addition
-
Remicade (infliximab) for IV Injection, Centocor, Prior Approval Efficacy
Supplement - Expanded Indication
-
Serevent Diskus (salmeterol xinafoate
inhalation powder), GlaxoSmithKline, Labeling Revision
Pharmaceutical Good Manufacturing Practices Guidances
- Draft Guidance for Industry: Quality Systems
Approach to Pharmaceutical Current Good Manufacturing Practice
Regulations [HTML] - [PDF]
- [Word]
-
Guidance for Industry: PAT — A Framework for
Innovative Pharmaceutical Development, Manufacturing, and
Quality Assurance [HTML]
- [PDF] - [Word]
-
Guidance for Industry: and FDA — Current Good
Manufacturing Practice for Combination Products [HTML]
- [PDF] - [Word]
- Guidance for Industry: Sterile Drug Products
Produced by Aseptic Processing — Current Good Manufacturing
Practice [HTML] - [PDF]
- [Word]
- Draft Guidance for Industry Computerized Systems
Used in Clinical Trials [HTML]
- [PDF] - [Word]
September 28, 2004
September 27, 2004
-
New and Generic Drug Approvals
-
Actiq (oral transmucosal fentanyl citrate), Cephalon,
Labeling Revision
-
Dextrose
in Lactated Ringers Injection, B. Braun, Labeling Revision
-
EPIVIR- HBV (lamivudine)
tablets, GlaxoSmithKline, Labeling Revision
-
EPIVIR- HBV (lamivudine)
oral solution, GlaxoSmithKline, Labeling Revision
-
Fluxid (famotidine orally disintegrating tablets), Schwarz Pharma,
Approval
-
Dextrose
in Sodium Chloride Injection, B. Braun, Labeling Revision
-
Metformin Hydrochloride Extended-Release Tablets, Cobalt Pharma,
Tentative Approval
-
Oxycodone Hydrochloride Extended-Release Tablet, Impax
Labs, Approval
-
Potassium
Chloride in Dextrose and Sodium Chloride Injection, B. Braun, Labeling Revision
-
Potassium
Chloride in Sodium Chloride Injection, B. Braun, Labeling Revision
-
Potassium
Chloride in Dextrose Injection, B. Braun, Labeling Revision
-
URSO 250 and Ursodiol 500 mg Tablets, Axcan Scandipharm,
Labeling Revision
-
Warfarin Sodium Tablets, Genpharm,
Approval
-
Presentations from the Public Workshop: Scientific Considerations Related to
Developing Follow-On Protein Products, September 14-15, 2004
-
Therapeutic Biological Products Mailing Addresses (updated)
September 24, 2004
- FDA approved Palladone (hydromorphone hydrochloride
extended-release) Capsules for the management of persistent,
moderate to severe pain in patients requiring continuous,
around-the-clock opioid analgesia with a high potency opioid for
an extended period of time generally weeks to months or longer. [Information
Page]
- FDA approves first-time generic Bromocriptine Mesylate Tablets USP, 2.5 mg for the
treatment of dysfunctions associated with
hyperprolactinemia, infertility or hypogonadism. It
is also used for the treatment of signs and symptoms
of Parkinson’s disease. The reference listed drug is
Parlodel Tablets.
-
New and Generic Drug Approvals
-
Bromocriptine Mesylate Tablets, Mylan Pharma,
Approval
-
Clarithromycin
Tablets, Ranbaxy Inc., Approval
-
Clindamycin
Injection, Bedford Labs, Approval
-
Halobetasol Propionate Ointment, Agis
Industries, Tentative Approval
-
Ribavirin Capsule, Teva Pharma,
Tentative Approval
-
Prescription Drug
User Fee Act - User Fee Billable Therapeutic Products Approved Under Section
351 of the PHS Act; update to the list
-
Warning Letters and Notice of Violation
Letters to Pharmaceutical Companies
- Wyeth and FDA inform healthcare professionals of reports of
glass vial breakage of Protonix I.V. during attempts to connect
vials to spiked intravenous system adaptors.
MedWatch Safety Info.
September 23, 2004
-
New and Generic Drug Approvals
-
Aromasin (exemestane
tablets), Pfizer Inc., Labeling Revision
-
CANASA (mesalamine) Suppository, Axcan Scandipharm,
Labeling Revision
-
Ciprofloxacin
Injection, Bedford Labs, Tentative Approval
-
Diuril (chlorothiazide)
Tablets Merck & Co., Inc, Labeling Revision
-
Diuril (chlorothiazide)
Intravenous Injection Merck & Co., Inc, Labeling Revision
-
Diuril (chlorothiazide)
Oral Suspension Merck & Co., Inc, Labeling Revision
-
Ibuprofen Oral Suspension, Perrigo
R & D, Approval
September 22, 2004
-
New and Generic Drug Approvals
-
Humatrope (somatropin [rDNA
origin] Injection), Eli Lilly, Labeling Revision
-
Loratadine and Pseudoephedrine
Sulfate ER Tablets, Ranbaxy, Approval
-
Namenda
tablets, Forest Laboratories, Control Supplement
-
Regonol (pyridostigmine bromide) injection, Sabex
2002, Manufacturing Change or Addition
-
Tramadol Hydrochloride & Acetaminophen Tablet, Kali
Labs, Tentative Approval
-
Zetia (ezetimibe) Tablets, Schering
Corporation, Labeling Revision
- Warning Letters and Notice of Violation
Letters to Pharmaceutical Companies
September 21, 2004
-
New and Generic Drug Approvals
-
Cetirizine Hydrochloride Tablets, Teva Pharma,
Tentative Approval
-
Exelon (rivastigmine) capsules, Novartis Pharma,
Labeling Revision
-
Exelon (rivastigmine) oral solution, Novartis Pharma,
Labeling Revision
-
Gabapentin
Capsules, Mutual Pharmaceutical, Tentative Approval
-
Indium DTPA (Pentetate Indium Disodium
In 111), GE Healthcare, Labeling Revision
-
Levocarnitine Tablets, CorePharma,
Approval
-
Milrinone Lactate Injection, Apotex
Corp., Approval
-
Rilutek (riluzole) tablets, Aventis Pharma,
Labeling Revision
-
Teril (Carbamazapine) Oral Suspension, Taro Pharma,
Approval
September 20, 2004
September 17, 2004
-
Drug Shortage:
Discontinuation; Agenerase (amprenavir) 150mg capsule
-
FDA approves first-time generic Mesalamine Rectal Suspension,
USP (enema) for the treatment of mild to moderate ulcerative
colitis. The reference listed drug is Rowasa Rectal enema.
-
New and Generic Drug Approvals
-
Aldomet (methyldopa)
Tablets, Merck & Co., Labeling Revision
-
AtroPen
(atropine) Injection, Meridian Medical, Formulation Revision
-
Cyclosporine Oral Solution, Morton Grove Pharma,
Approval
-
Ergotamine Tartrate and caffeine, West-Ward Pharma,
Approval
-
Infuvite
Adult (multiple vitamins for infusion), Roundtable Healthcare, Labeling Revision
-
Kytril Injection, Hoffman-La Roche,
Formulation Revision & Manufacturing Change or Addition
-
Magnevist, (Gadopentetate Dimeglumine) Injection, Berlex,
Labeling Revision
-
Mesalamine
Rectal Suspension, Clay-Park Labs, Approval
-
Nicotine Polacrilex Gum (2mg Regular), L. Perrigo
Co., Approval
-
Nicotine Polacrilex Gum (2mg Orange), L. Perrigo
Co., Approval
-
Nicotine Polacrilex Gum (2mg Mint), L. Perrigo
Co., Approval
-
Nicotine Polacrilex Gum (4mg Orange), L. Perrigo
Co., Approval
-
Nicotine Polacrilex Gum (4mg Mint), L. Perrigo
Co., Approval
-
Nicotine Polacrilex Gum (4mg Regular), L. Perrigo
Co., Approval
-
Ultravate (halobetasol
propionate) Ointment, Bristol Myers Squibb, Labeling Revision
-
Ultravate (halobetasol
propionate) Cream, Bristol Myers Squibb, Labeling Revision
September 16, 2004
September 15, 2004
- NDA Approvals for Calendar Year 2004 (Updated)
-
New and Generic Drug Approvals
-
Avodart (dutasteride)
soft-gelatin capsules, GlaxoSmithKline, Efficacy Supplement with Clinical Data
to Support
-
Avodart (dutasteride)
soft-gelatin capsules, GlaxoSmithKline, Supplement
-
FLOXIN (ofloxacin
tablets) Tablets, Johnson & Johnson, Labeling Revision
-
Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline
hydrochloride), Prometheus Laboratories, Labeling Revision
-
Rocephin (ceftriaxone sodium) for injection, Hoffman- La Roche,
Supplement
-
Rocephin (ceftriaxone Injection), Hoffman- La Roche,
Supplement
- New Molecular Entities (NMEs) Approved in Calendar
Year 2004 (Updated)
September 14, 2004
-
New and Generic Drug Approvals
-
Avodart (dutasteride)
soft-gelatin capsules, GlaxoSmithKline, Efficacy Supplement with Clinical Data
to Support
-
EstroGel (estradiol gel), Solvay
Pharmaceuticals, Labeling Revision
-
LEVAQUIN (levofloxacin) Tablets R.W.
Johnson Pharmaceutical, Labeling Revision
-
LEVAQUIN (levofloxacin) Injection, R.W.
Johnson Pharmaceutical, Labeling Revision
-
Rocephin (ceftriaxone sodium) for injection, Hoffman- La Roche,
Labeling Revision
-
Rocephin (ceftriaxone injection), Hoffman- La Roche,
Labeling Revision
-
Tequin (gatifloxacin)
Tablets, Bristol Myers-Squibb, Labeling Revision
-
Tequin (gatifloxacin
in 5% dextrose) Injection, Bristol Myers-Squibb, Labeling Revision
-
Vioxx (rofecoxib) Tablets, Merck & Co., Labeling Revision
-
Vioxx (rofecoxib) Suspension, Merck & Co., Labeling Revision
September 13, 2004
September 10, 2004
-
E14 Clinical Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential for Non-Antiarrhythmic Drugs [HTML]
or [PDF]
or [Word]
-
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular
Repolarization (QT Interval Prolongation) by Human Pharmaceuticals [HTML]
or [PDF]
or [Word]
-
New and Generic Drug Approvals
-
Amantadine Hydrochloride Syrup, Silarx
Pharmaceuticals, Approval
-
Brimonidine Tartrate Ophthalmic Solution, Ivax Pharma,
Approval
-
Ciprofloxacin
Tablets, Unique Pharmaceutical, Approval
-
Fluticasone Propionate Cream, KV
Pharmaceutical, Approval
-
INVANZ (Ertapenem
for Injection), Merck & Co., Labeling Revision
-
M.V.I.-12 (multi-vitamin infusion without vitamin K), Mayne Pharma,
New or Modified Indication
- Public Workshop: Scientific Considerations Related to Developing
Follow-On Protein Products, September 14-15, 2004. Federal Register
Notice: [TXT]
[PDF]
Agenda
September 9, 2004
September 8, 2004
-
New and Generic Drug Approvals
-
FACTIVE (gemifloxacin mesylate) Tablets, Parexel
International, Labeling Revision
-
NegGram (nalidixic
acid) Caplets, Sanofi-Synthelabo, Labeling Revision
-
NegGram (nalidixic
acid) Suspension, Sanofi-Synthelabo, Labeling Revision
- Office of Generic Drugs (updated)
September 7, 2004
- FDA approves Cymbalta (duloxetine hydrochloride) capsules for
the management of the pain associated with diabetic peripheral
neuropathy.
FDA News.
-
New and Generic Drug Approvals
-
Cymbalta (duloxetine
hydrochloride) Delayed- release Capsules, Lilly Research, Approval
-
Human Secretin for Injection, ChiRhoClin,
Labeling Revision
-
Levo-Dromoran (levorphanol tartrate) Tablets, Valeant
Pharmaceuticals, Manufacturing Change or Addition
- Pediatric Drug Development
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Date revised:
October 29, 2004 |
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