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CDER News Items 2006
December 27, 2006
- FDA approves first-time generic ondansetron to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy. The reference listed drug is Zofran. FDA News
December 22, 2006
- FDA issues an updated Public Health Advisory and Healthcare Professional sheet on gadolinium-based contrast agents. Gadolinium Information
December 20, 2006
- FDA approves Colazal (balsalazide disodium) for the treatment of mildly to moderately active ulcerative colitis in patients 5 to 17 years of age. FDA News
- FDA approves Invega (paliperidone), a new molecular entity, for the treatment of schizophrenia. FDA News
December 20, 2006
- FDA approves Invega (paliperidone), a new molecular entity, for the treatment of schizophrenia. FDA News
December 19, 2006
- FDA proposes to amend the labeling regulations to add important safety information for OTC pain relievers. FDA News
December 18, 2006
- FDA issues a Public Heath Advisory and Healthcare Professional Sheet on Rituxan (rituximab). Rituxan Information
December 15, 2006
- FDA revises labeling for Trasylol (Aprotinin Injection) to strengthen safety warnings and limit usage to specific situations. Trasylol Information
- FDA approves Celebrex (celecoxib) to treat juvenile rheumatoid arthritis in patients two years of age and older. FDA News
- FDA approves Cyanokit (containing the drug hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with saline) for the treatment of known or suspected cyanide poisoning. FDA News
December 14, 2006
- FDA approves first-time generic bupropion hydrochloride to treat major depressive disorder. The reference listed drug is Wellbutrin. FDA News
December 12, 2006
- FDA orders unapproved quinine drugs from the market and cautions consumers about “off-label” use of quinine to treat leg cramps. FDA News
December 11, 2006
- FDA proposes rules overhaul to expand the availability of experimental drugs. The Agency also clarifies permissible charges to patients. FDA News
December 8, 2006
- FDA and Baxter notify healthcare professionals of revisions to the Warnings section of the prescribing information for Heparin to inform clinicians of the possibility of delayed onset of heparin-induced thrombo- cytopenia. MedWatch Safety Information
- FDA approves bortezomib (Velcade), a proteasome inhibitor, for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
December 7, 2006
A joint meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will be held on December 14th and 15th, 2006. The location has been changed to the Hilton Hotel, Maryland Ballrooms, 8727 Colesville Road, Silver Spring, MD. Federal Register notice
December 6, 2006
- FDA notifies healthcare professionals and consumers about the serious public health risks related to compounded topical anesthetic creams. MedWatch Safety Information
December 1, 2006
- FDA approves first-time generic oxandrolone to promote weight gain after weight loss after extensive surgery. The reference listed drug is Oxandrin.
November 27, 2006
- FDA issues a Public Health Advisory and Healthcare Professional Sheet for methadone. Methadone Information
November 22, 2006
- FDA and Advanced Medical Optics, Inc. inform healthcare professionals and consumers of a nationwide recall of 18 lots of Complete MoisturePLUS multipurpose contact lens care solution and Active Packs. MedWatch Safety Information
- FDA approves first-time generic ondansetron for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. The reference listed drug is Zofran. FDA News
November 17, 2006
- FDA approves first-time generic sulfacetamide for the topical treatment of acne vulgaris. The reference listed drug is Klaron Lotion.
November 16, 2006
- FDA expands use of Herceptin for early stage breast cancer. FDA News
- FDA issues an Alert and a Public Health Advisory and a Healthcare Professional Information Sheets for the Erythropoesis-Stimulating Agents [Epoetin alfa (marketed as Procrit and Epogen) and Darbepoetin alfa (marketed as Aranesp)] Information
November 15, 2006
- Postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. MedWatch Safety Information
November 9, 2006
- FDA alerts the public of a nationwide recall of 500mg strength store-brand acetaminophen caplets. FDA News
November 2, 2006
November 1, 2006
- FDA approves first-time generic MetroGel-Vaginal (metronidazole vaginal gel), to treat bacterial vaginosis. FDA News
October 26, 2006
- FDA approves Tyzeka (telbivudine) for the treatment of adults with chronic hepatitis B (HBV). FDA News
October 25, 2006
- Wyeth and FDA notify healthcare professionals of revisions to the Overdosage/Human Experience section of the prescribing information for Effexor (venlafaxine HCl), indicated for treatment of major depressive disorder. MedWatch Safety Information
- Heartland Repack Services and FDA notify healthcare professionals of a voluntary recall of all products containing a lot number beginning with “K” (example: K12345). MedWatch Safety Information
October 23, 2006
- FDA approves Omnaris (ciclesonide) nasal spray for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, commonly known as hay fever. FDA News
October 20, 2006
- FDA is extending the expiration date to May 1, 2007 for the use of the prior version of Form FDA 3500A for "MedWatch: Food and Drug Administration Medical Products Reporting Program" (the MedWatch Program). Federal Register Notice [TXT] [PDF]
MedWatch Reporting Forms
October 19, 2006
- Novartis and FDA notify healthcare professionals about the occasional occurrence of severe congestive heart failure and left ventricular dysfunction in patients taking Gleevec. MedWatch Safety Information
- Steven Galson, CDER Center Director, announces changes to the process FDA uses to prioritize the review of generic drug applications. Presentation
October 18, 2006
- FDA approves Taxotere (docetaxel) for use in combination with cisplatin and fluorouracil prior to radiotherapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck. FDA News
October 17, 2006
- FDA approves Januvia (sitagliptin phosphate), the first diabetes treatment approved in a new class of drugs known as DDP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar. FDA News
October 13, 2006
- FDA approves Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer's Disease. FDA News
October 12, 2006
- FDA approves Avastin (bevacizumab) in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer. FDA News
October 10, 2006
- FDA and Bristol-Myers Squibb notify pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients. MedWatch Information
- FDA approves Risperdal (risperidone) for the symptomatic treatment of irritability in autistic children and adolescents. FDA News
October 6, 2006
- FDA provides an update about iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne). Isotretinoin and iPLEDGE Information
September 29, 2006
- FDA issues an Alert and Patient and Healthcare Professional Information Sheets for Lamictal (lamotrigine). Lamictal Information
- FDA issues a Public Health Advisory regarding new Trasylol (aprotinin) data, and updates the Patient and Healthcare Professional Information sheets. Trasylol Information
September 27, 2006
- FDA approves Vectibix (panitumumab) for the treatment of patients with colorectal cancer that has metastasized following standard chemotherapy. FDA News
September 26, 2006
- FDA releases a statement by Steven Galson, CDER Director, regarding the Institute of Medicine's "Future of Drug Safety" Report. Statement
September 25, 2006
- FDA changes the prescribing information for Avastin (bevacizumab) to warn providers about risk of posterior leukoencephalopathy neurological syndrome and nasal septum perforation. MedWatch Information Labeling
- FDA approves Fentora (fentanyl buccal tablets) for the management of breakthrough pain in patients with cancer who are already receiving, and who are tolerant to opioid therapy for their underlying persistent cancer pain.
September 21, 2006
- FDA approves first-time generic caffeine citrate to treat short term apnea in premature infants between 28 and 33 weeks gestational age. The reference listed drug is Cafcit.
September 20, 2006
- FDA updates the labeling for Ortho Evra (norelgestromin/ethinyl estradiol) with new safety information. Ortho Evra is a contraceptive skin patch used to prevent pregnancy. Ortho Evra Information
September 19, 2006
- FDA approves first-time generic prednicarbate cream to relieve the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. The reference listed drug is Dermatop.
September 18, 2006
- FDA approves Noxafil (posaconazole) to prevent
invasive fungal infections. FDA News
September 11, 2006
- FDA approves first-time generic topiramate tablets, 25
mg, 100 mg, and 200 mg to treat epilepsy. The reference listed drug is Topamax.
September 8, 2006
- FDA issues a Healthcare Professional Sheet and new
information about concomitant use of ibuprofen and aspirin. Ibuprofen Info. Aspirin Info.
September 6, 2006
- FDA approves generic Quasense Tablets (levonorgestrel
and ethinyl estradiol) as an extended-cycle oral contraceptive for prevention of
pregnancy. The reference listed drug is Seasonale.
- FDA approves first-time generic loperamide
hydrochloride and simethicone tablets to control symptoms of diarrhea plus
bloating, pressure and cramps. The reference listed drug is Imodium.
September 5, 2006
- Considerations for Discussion by National Regulatory
Authorities with WHO On Possible International Non-proprietary Name Policies for
Biosimilars. FDA Statement
August 28, 2006
- FDA approves first-time generic Ciprofloxacin
Injection USP.
FDA News.
August 24, 2006
- FDA approves Plan B, a contraceptive drug, as an
over-the-counter (OTC) option for women aged 18 and older.
Plan B Information
August 23, 2006
August 21, 2006
- FDA and GlaxoSmithKline notify healthcare
professionals of changes to the labeling for Dexedrine (dextroamphetamine
sulfate), approved for the treatment of Attention-Deficit Hyperactivity Disorder
and narcolepsy.
MedWatch Information
August 10, 2006
- FDA warns three firms, RoTech Healthcare, Inc.,
CCS Medical, and Reliant Pharmacy Services, to stop manufacturing and
distributing thousands of doses of compounded, unapproved inhalation drugs
nation-wide.
MedWatch Safety Information
August 4, 2006
- Luitpold Pharmaceuticals, Inc. and FDA notify
healthcare professionals of a voluntary recall of some vials of Hydralazine HCl
because they may contain particulates.
MedWatch Safety Information
August 3, 2006
- FDA approves first-time generic venlafaxine to treat
depression. The Reference Listed Drug is Effexor.
FDA News
August 2, 2006
- FDA approves first-time generic trimpiramine maleate to
treat symptoms of depression. The Reference Listed Drug is Surmontil.
July 31, 2006
- FDA announces a framework for moving emergency
contraception medication to over-the-counter status.
FDA Statement
July 28, 2006
- FDA approves first-time generic finasteride to treat male pattern
hair loss. The Reference Listed Drug is Propecia.
July 25, 2006
- FDA expands the approved use of Oncaspar (pegaspargase)
to include treating children and adults with newly diagnosed acute lymphoblastic
leukemia as part of a multiple drug chemotherapy regimen.
FDA News
July 24, 2006
- FDA approves a new type of over-the-counter
sunscreen product.
FDA News
- FDA approves Elaprase (idursulfase), the first product
for the treatment of Hunter syndrome.
FDA News
July 21, 2006
- FDA warns consumers and healthcare providers not to
use bismacine, also known as chromacine, to treat Lyme disease.
MedWatch Safety Information
- Berlex, Inc. and FDA announce a voluntary nationwide
recall of a single lot Ultravist (iopromide) due to the presence of particulate
matter in conjunction with crystallization.
MedWatch Information
July 19, 2006
- FDA issues a
Public Health Advisory: Combined
Use of 5-Hydroxytryptamine Receptor Agonists (Triptans), Selective Serotonin
Reuptake Inhibitors (SSRIs) or Selective Serotonin/Norepinephrine Reuptake
Inhibitors (SNRIs) May Result in Life-threatening Serotonin Syndrome.
- FDA issues a
Public Health Advisory:
Treatment Challenges of Depression in Pregnancy.
- FDA approves first-time generic meloxicam to
treat osteoarthritis. The Reference Listed Drug is Mobic.
FDA News
July 14, 2006
- FDA approves Gemzar (gemcitabine) in
combination with carboplatin for the treatment of patients with advanced ovarian
cancer that has relapsed at least 6 months after completion of platinum based
therapy.
Gemzar Label
July 13, 2006
- Azathioprine Tablets, 50 mg - Recalled due to a
packaging mixup with Methotrexate.
MedWatch.
July 12, 2006
- FDA approves Atripla, a fixed-dose combination of three
widely-used antiretroviral drugs, in a single tablet taken once a day,
alone or in combination with other antiretroviral products for the
treatment of HIV-1 infection in adults.
Drug Information
July 3, 2006
- FDA grants tentative approval to a three-component AIDS drug in association with
the President's Emergency Plan for AIDS Relief.
FDA News
- FDA approves Lucentis (ranibizumab injection)
for the treatment of patients with neovascular (wet) age-related macular
degeneration.
FDA News
June 30, 2006
- FDA completes its safety assessment of Ketek (telithromycin)
and advises health practitioners and patients to be aware of rare but
potentially serious health risks.
MedWatch
Safety Information
- FDA approves first-time generic sertraline to
treat major depressive disorder. The Reference Listed Drug is Zoloft.
FDA News
- Boehringer Ingelheim and FDA inform healthcare
professionals of important new safety information for Aptivus (tipranavir)
capsules.
MedWatch Safety Information
June 29, 2006
- FDA approves Sprycel (dasatinib), a new oral
treatment for patients with chronic myeloid leukemia.
FDA News
- FDA approves first-time generic tranylcypromine
sulfate to treat depression. The Reference Listed Drug is Parnate.
June 27, 2006
- FDA tentatively approves first-time generic
abacavir, another pediatric AIDS drug, in association with the President’s
Emergency Plan for AIDS Relief.
FDA News
- FDA approves Exelon (rivastigmine tartrate) to
treat mild to moderate dementia associated with Parkinson's disease.
FDA News
June 23, 2006
- FDA approves first-time generic simvastatin to
treat hypercholesterolemia (high cholesterol). The Reference Listed Drug is
Zocor. FDA News
June 20, 2006
- FDA warns consumers not to use Triaminic Vapor
Patch because of
possible safety and health risks to children.
Public Health Advisory.
June 19, 2006
- FDA approves first-time generic finasteride to
treat symptomatic benign prostatic hyperplasia. The Reference Listed Drug is
Proscar.
June 15, 2006
- FDA approves a combination of Hycamtin (topotecan
hydrochloride) and cisplatin for use as the first drug treatment for women with
late-stage cancer of the cervix.
FDA News.
June 8, 2006
- FDA issues a Public Health Advisory and
Healthcare Professional Sheet for gadolinium-containing contrast agents and a
disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing
Dermopathy. Drug Information.
- FDA issues a final guidance to strengthen its
efforts against unapproved drug products.
More Information.
June 7, 2006
- FDA issues a Public Health Advisory and Patient
and Healthcare Professional Information Sheets for Angiotensin-Converting Enzyme
Inhibitors (ACE inhibitors) and pregnancy.
Drug Information
June 5, 2006
- FDA approves an application for resumed
marketing of Tysabri (natalizumab) with a special restricted distribution
program. Tysabri Information
May 30, 2006
- FDA approves Omnitrope (somatropin [rDNA
origin]), for long-term treatment of pediatric patients who have growth failure
due to an inadequate secretion of endogenous growth hormone, and for long-term
replacement therapy in adults with GHD of either childhood or adult onset.
Drug Information.
May 24, 2006
- FDA approves first-time generic metronidazole topical lotion to treat rosacea.
The Reference Listed Drug is MetroLotion Topical Lotion.
May 22, 2006
- FDA approves first-time generic escitalopram oxalate to treat major depressive
disorder. The Reference Listed Drug is Lexapro.
May 19, 2006
- Spectrum Laboratory Products and FDA notify healthcare professionals of the
recall of the active pharmaceutical ingredient tacrolimus after learning that
some lots of the ingredient are subpotent.
MedWatch Safety Information
- FDA approves Remicade for children with Crohn’s Disease.
Remicade Information
- FDA approves first-time generic cefdinir capsules to treat mild to moderate
infections. The Reference Listed Drug is Omnicef.
May 18, 2006
- FDA approves Azilect (rasagiline), a new molecular entity, for the treatment of
Parkinson's disease.
FDA News
May 12, 2006
- GlaxoSmithKline and FDA notify healthcare professionals of changes to the
Clinical Worsening and Suicide Risk subsection of the Warnings section in the
prescribing information for Paxil and Paxil CR.
MedWatch
Safety Information
May 11, 2006
- FDA approves Chantix (varenicline tartrate) tablets to help cigarette smokers
stop smoking.
FDA News
May 5, 2006
- FDA issues an FDA Alert and Patient and Healthcare Professional Safety Sheets
for oral sodium phosphate products for bowel cleansing.
Drug Information
May 3, 2006
- FDA approves Dacogen (decitabine) injection for the treatment of myelodysplastic
syndromes. Dacogen is a new molecular entity that received orphan drug status.
FDA News
- • May 3.
FDA and IVAX Pharmaceuticals, Inc. notify healthcare professionals of a recall
of Goldline brand Extra Strength Genapap 500mg (Acetaminophen) Caplets and
Tablets and Extra Strength Genebs 500mg (Acetaminophen) Caplets and Tablets due
to a labeling error.
MedWatch
Safety Information
May 2, 2006
- FDA approves first-time generic colestipol hydrochloride as an adjunctive
therapy to diet for the reduction of elevated serum total and low-density
lipoprotein cholesterol in patients with primary hypercholesterolemia who do not
respond adequately to diet. The reference listed drug is Colestid.
April 28, 2006
- FDA approves Myozyme (alglucosidase alfa, rhGAA), the first treatment for
patients with Pompe disease, a rare but severely debilitating disease.
FDA News
April 25, 2006
- FDA issues an FDA Alert and Patient and Healthcare Professional Safety Sheets
for Promethazine HCI, marketed as Phenergan.
More Information
April 24, 2006
- FDA approves first-time generic Pravastatin Sodium Tablets to treat individuals
with high cholesterol levels, or who are at increased risk for
atherosclerosis-related cardiac and cardiovascular events. The Reference Listed
Drug is Pravachol.
FDA News
April 11, 2006
- FDA approves first-time generic mitoxantrone hydrochloride. The Reference Listed
Drug is Novantrone.
April 7, 2006
- Pfizer Pharmaceuticals notifies healthcare professionals of labeling changes for Macugen (pegaptanib sodium injection), to address rare reports of anaphylaxis/anaphylactoid
reactions.
MedWatch
Safety Information
April 4, 2006
- FDA co-sponsors a hands-on workshop on implementing the Final Rule on the
Content and Format of Prescription Drug Labeling.
Meeting information
March 30, 2006
March 28, 2006
- FDA approves first-time generic zidovudine capsules,100 mg, to be used in
combination with other anti-retroviral medications to treat HIV infection. This
product was reviewed under the President's Emergency Plan for AIDS Relief.
March 27, 2006
- FDA approves first-time generic Glipizide Extended-release Tablets, 2.5 mg for
the control of hyperglycemia in patients with type 2 diabetes. The Reference
Listed Drug is Glipizide Extended-release Tablets, 2.5 mg.
March 17, 2006
- FDA issues a Public Health Advisory on sepsis and medical abortion with mifepristone (Mifeprex). Public
Health Advisory
March 15, 2006
- Ligand Pharmaceuticals and FDA notify healthcare professionals of changes to the
Warnings section of the prescribing information for Ontak.
MedWatch
Safety Information
March 10, 2006
- FDA warns manufacturers about illegal steroid products sold as dietary
supplements. FDA
News
March 7, 2006
- FDA issues an FDA Alert plus Healthcare Professional and Patient Safety Sheets
for Tequin (gatifloxacin).
Tequin Information
March 2, 2006
- Actelion and FDA notify healthcare professionals of changes to the prescribing
information for Tracleer (bosentan) based on cases of hepatotoxity reported.
MedWatch
Safety Information
- FDA approves new labeling and medication guides for Serevent Diskus (salmeterol
xinafoate) and Advair Diskus (fluticasone propionate; salmeterol xinafoate).
More Information
March 1, 2006
- Hanford Pharmaceuticals and FDA notify healthcare professionals about the recall
of four lots Cefazolin for Injection
MedWatch Safety Information
- FDA approves Erbitux (cetuximab) for use in combination with radiation therapy
to treat patients with squamous cell cancer of the head and neck that can not be
removed by surgery.
FDA News
February 28, 2006
- FDA approves Emsam (selegiline) as the first transdermal skin patch for treating major depression.
FDA News
- FDA approves a new indication for Rituxan (rituximab) in combination
with methotrexate to reduce the signs and symptoms in adult patients with
moderately- to severely-active rheumatoid arthritis.
February 23, 2006
- FDA and manufacturers of Accutane and its
generics will implement the iPLEDGE Program as planned on March 1, 2006.
FDA News
February 22, 2006
- FDA approves first-time generic Fluticasone
Propionate Nasal Spray for the management of the nasal symptoms of seasonal and
perennial allergic and nonallergic rhinitis in adults and pediatric patients 4
years of age and older.
FDA News
February 17, 2006
- FDA approves a new molecular entity, Eraxis (anidulafungin)
to treat patients with esophageal candidiasis, candidemia, and other forms of
Candida infections.
FDA News
February 10, 2006
- FDA approves Rituxan (rituximab)
for use in the first line treatment of patients with diffuse
large B-cell, CD20 positive, non-Hodgkin’s lymphoma in
combination with CHOP or other anthracycline based
chemotherapy regimens.
February 8, 2006
February 1, 2006
- FDA approves
first-time generic Nicotine Polacrilex Lozenges to reduce
withdrawal symptoms associated with quitting smoking. The
reference listed drug is Commit.
January 31, 2006
- FDA approves Ranexa (ranolazine),
a new drug for the treatment of chronic angina.
FDA News.
January 30, 2006
January 27, 2006
- FDA approves first-time generic Alprazolam Extended-release
Tablets to treat anxiety disorders. The reference listed drug is Xanax
XR.
- FDA approves Exubera, the
first ever inhaled insulin combination product for the
treatment of diabetes.
FDA News.
January 26, 2006
- FDA approves Sutent (sunitinib), a new treatment for
gastrointestinal and kidney cancer.
FDA
News
January 26, 2006
- FDA and Bristol-Myers Squibb notify healthcare professionals about
revisions to the prescribing information for Hydrea (hydroxyurea
capsules) and Droxia (hydroxyurea capsules).
MedWatch Info
January 20, 2006
January 19, 2006
- FDA approves updated labeling with a boxed warning and Medication
Guide for two eczema drugs, Elidel and Protopic.
Elidel Info.
Protopic Info.
January 18, 2006
January 13, 2006
- Novartis and FDA notify healthcare professions of revisions to
sections of the prescribing information for Clozaril (clozapine)
tablets.
MedWatch Safety Information
- FDA warns consumers not to use Brazilian Diet Pills (Emagrece Sim
and Herbathin products. They may contain active ingredients found in
prescription drugs that could lead to serious side effects or injury.
MedWatch Safety Information
January 12, 2006
- FDA issues advice to make the earliest stages of clinical drug
development more efficient.
FDA
News
January 11, 2006
January 4, 2006
- FDA approves ten applications for generic Zonisamide capsules for
adjunctive therapy in the treatment of partial seizures in adults with
epilepsy. The reference listed drug is Zonegran.
- FDA approves Femara (letrozole tablets) for the adjuvant treatment
of postmenopausal women with hormone receptor positive early breast
cancer.
- FDA approves ten applications for generic Zonisamide capsules for
adjunctive therapy in the treatment of partial seizures in adults with
epilepsy. The reference listed drug is Zonegran.
- FDA approves Orencia (abatacept).
- FDA approves first-time generic Cabergoline tablets for treatment
of hyperprolactinemic disorders, either idiopathic or due to pituitary
adenomas. The reference listed drug is Dostinex.
- FDA approves Femara (letrozole tablets) for the adjuvant treatment
of postmenopausal women with hormone receptor positive early breast
cancer.
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Date created: January 4, 2006; Last updated: January, 2008 |
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