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CDER News Items 2004
December 28, 2004
- FDA approves CLOLAR (clofarabine) Intravenous Infusion for the
treatment of pediatric patients 1 to 21 years old with relapsed or
refractory acute lymphoblastic leukemia after at least two prior
regimens.
- FDA approves Prialt (ziconotide intrathecal infusion) for the
management of severe chronic pain in patients for whom intrathecal
(IT) therapy is warranted and who are intolerant of or refractory to
other treatment, such as systemic analgesics, adjunctive therapies, or
IT morphine.
December 27, 2004
- FDA approves first time generic Clindamycin Phosphate Vaginal
Cream USP, 2% (base) for the treatment of bacterial vaginosis. The
reference listed drug is Cleocin.
December 23, 2005
December 22, 2004
- FDA and Centocor revise the labeling for Remicade to include a
warning on severe hepatic reactions. Remicade is used to treat
rheumatoid arthritis, Crohn's disease and ankylosing spondylitis.
MedWatch Safety Info
December 21, 2004
- FDA advises patients who are currently taking over-the-counter
naproxen products to carefully follow the instructions on the label.
FDA
Statement
- FDA asks Pfizer, Inc. to voluntarily suspend direct-to- consumer
advertising on Celebrex during the time the Agency is obtaining and
evaluating the new and conflicting scientific data on adverse events
associated with the drug.
FDA
Statement
December 20, 2004
- December 20. FDA approves Macugen (pegaptanib sodium injection), a
new therapy to slow vision loss in people with the eye disease
neovascular (wet) age-related macular degeneration (AMD).
FDA
News.
December 17, 2004
- FDA asks the manufacturer of Strattera to add a bolded warning
about the potential of severe liver injury to the labeling.
FDA
Talk Paper
- FDA releases a statement regarding the failure of a clinical trial
of Iressa (gefitinib) to show an overall survival advantage in
treating patients with lung cancer.
FDA
Statement
- FDA releases a statement on the halting of a clinical trial of the
Cox-2 inhibitor Celebrex.
Celebrex Information
December 16, 2004
- FDA approves VisionBlue (trypan blue ophthalmic solution) as an
aid in ophthalmic surgery by staining the anterior capsule of the
lens.
FDA
Talk Paper
- FDA approves first-time generic Halobetasol Propionate Ointment, a
super-high potency corticosteroid for the relief of the inflammatory
and pruritic manifestations of corticosteroid-responsive dermatoses.
The reference listed drug is Ultravate.
December 15, 2004
- FDA approves Palifermin, a modified version of a naturally
occurring human protein called keratinocyte growth factor.
Palifermin Information.
- FDA approves first-time generic Quinapril Tablets USP, 5 mg, 10
mg, 20 mg, and 40 mg. The reference drug is Accupril.
December 13, 2004
- FDA approves first-time generic Citalopram Hydrobromide 10 mg
(base) /5 mL Oral Solution for the treatment of depression. The
reference listed drug is Celexa.
December 9, 2004
- FDA approves a new label with upgraded warnings for Bextra. Bextra
is a type of pain medication, called COX-2 selective non-steroidal
anti-inflammatory drugs (NSAIDs), used to treat arthritis and
menstrual pain. Bextra
Information
- FDA warns consumers about purchase and use of Carbolith 150
Milligram Capsules, an unapproved product that might be substandard.
MedWatch Safety Info
December 8, 2004
- December 8. Ortho Biotech Products notifies healthcare
professionals of important changes to the safety information and
dosing sections of the product labeling for Procrit.
MedWatch Safety Info
December 7, 2004
- FDA releases questions and answers concerning the use of the
antidepressant drug Effexor (venlafaxine) and the class of
antidepressant drugs known as selective serotonin reuptake inhibitors,
or SSRIs in adults.
Effexor Information
December 6, 2004
- FDA approves first-time generic Fosinopril Sodium and
Hydrochlorothiazide Tablets for the treatment of hypertension. The
reference listed drug is Monopril HCT.
December 1, 2004
- FDA strengthens the labels of two specific types of antibiotics to
ensure their proper use.
FDA
Talk Paper.
November 30, 2004
- King Pharmaceuticals and FDA remind healthcare professionals of
postmarketing reports of inappropriate use of Bicillin C-R to treat
patients infected with syphilis.
MedWatch Safety Info.
November 24, 2004
- FDA licenses a new biologic approach to treat patients with
relapsing forms of multiple sclerosis to reduce the frequency of
symptom flare-ups or exacerbations of the disease.
Tysabri Information
November 18, 2004
- FDA announces that a "black box" warning highlighting prolonged
use may result in the loss of bone density, will be added to the
labeling of Depo-Provera Contraceptive Injection, an established
injectable drug approved for use in women to prevent pregnancy.
MedWatch Safety Info.
November 15, 2004
- FDA announces important labeling changes for Mifeprex
(mifepristone, also known as RU-486).
Mifeprex Info.
November 12, 2004
- 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 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.
November 5, 2004
November 4, 2004
October 29, 2004
- 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.
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.
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.
More Information.
October 14, 2004
- 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
- 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.
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.
- 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.
October 4, 2004
- 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.
September 30, 2004
- FDA issues a Public Health Advisory on Vioxx as its manufacturer
voluntarily recalls the product.
Vioxx Information.
September 29, 2004
- FDA issues the final report on its 21st Century Initiative on the
Regulation of Pharmaceutical Manufacturing.
FDA
News. Final Report.
September 28, 2004
- FDA approves first-time generic Dexrazoxane for use as a
cardioprotective agent in conjunction with Doxorubicin. The reference
listed drug is Zinecard.
September 24, 2004
- 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.
- 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.
- FDA approves 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
September 20, 2004
- FDA approves first-time generic Levocarnitine Tablets for the
treatment of primary systemic carnitine deficiency. The reference
listed drug is Carnitor Tablets, 330 mg, of Sigma Tau Pharmaceuticals,
Inc.
September 17, 2004
- 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.
September 7, 2004
- FDA approves Cymbalta (duloxetine hydrochloride) capsules for the
management of the pain associated with diabetic peripheral neuropathy.
FDA
News.
August 31, 2004
- FDA and Pfizer notified healthcare professionals of revision to
the WARNINGS section of labeling for Geodon (ziprasidone), describing
the risk of hyperglycemia and diabetes in patients taking Geodon.
MedWatch Safety Info.
August 26, 2004
- FDA approves Allopurinol Sodium for Injection for the management
of patients with leukemia, lymphoma, and solid tumor malignancies who
are receiving cancer therapy. The reference listed drug is Aloprim.
August 24, 2004
- FDA and Centocor revise the labeling for Remicade, used to treat
rheumatoid arthritis and Crohn's disease. Cases of leukopenia,
neutropenia, pancytopenia, and CNS manifestation of systemic
vasculitis were described in patients receiving Remicade.
MedWatch Safety Info.
August 20, 2004
- FDA updates its review of antidepressant drugs in children. FDA’s
next step will be to update the Psychopharmacologic Drugs and the
Pediatric Advisory Committees about the results of these reviews and
consider what additional regulatory actions may be needed to promote
the safe use of these drugs.
FDA
Talk Paper.
- FDA approves Alimta (pemetrexed for Injection) as a single-agent
for the treatment of patients with locally advanced or metastatic
non-small cell lung cancer after prior chemotherapy.
August 17, 2004
- FDA and Aventis Pharmaceuticals revise the labeling for Lovenox,
describing the need for a dosage adjustment for patients with severe
renal impairment who have increased exposure to enoxaparin.
MedWatch Safety Info.
August 13, 2004
- FDA and Genentech, Inc. issue an important drug warning to
healthcare providers that there is evidence of an increased risk of
serious arterial thromboembolic events related to Avastin.
MedWatch Safety Info.
August 11, 2004
- FDA Approves Drugs to Treat Internal Contamination from
Radioactive Elements. More
Info
August 10, 2004
- FDA approves Esmolol Hydrochloride Injection, a beta-selective (cardioselective)
adrenergic receptor blocking agent with a very short duration of
action. The reference listed drug is Brevibloc Injection of Baxter
Healthcare.
- FDA approves first-time generic Levocarnitine Oral Solution,
1g/10mL, for the treatment of carnitine deficiency. The reference
listed drug is Carnitor Oral Solution
August 6, 2004
- FDA approves first-time generic Ciclopirox Topical Suspension USP,
0.77% (lotion) as a topical antifungal. The reference listed drug is
Loprox Topical Suspension, 0.77% of Medicis Pharmaceutical Corp.
August 5, 2004
- FDA approves Humira (adalimumab) to improve physical function in
adult patients with moderately to severely active rheumatoid arthritis
who have had an inadequate response to one or more disease-modifying
anti-rheumatic drugs.
August 3, 2004
- FDA approves Sculptra, an injectable filler to correct facial fat
loss in people with human immunodeficiency virus (HIV) infection.
FDA
News
August 2, 2004
- FDA approves Epzicom (abacavir/lamivudine) and Truvada (tenofovir
disoproxil/emtricitabine), two fixed-dose combination treatments for
HIV-1 infection.
FDA
News.
July 30
- FDA approves Campral (acamprosate) for treating alcohol dependent
individuals seeking to continue to remain alcohol-free
after they have stopped drinking.
FDA
Talk Paper
July 29
- FDA approves first-time generic Clotrimazole Lozenges USP, 10 mg
for the treatment of oropharyngeal candidiasis. The reference listed
drug is Mycelex Troche, 10 mg.
July 29
- FDA approves first-time generic Clotrimazole and Betamethasone
Dipropionate Lotion, 1%/0.05% (base) as an anti-inflammatory. The
reference listed drug is Lotrisone Lotion.
July 28
- FDA approves first-time generic medroxyprogesterone acetate
injectable suspension for the prevention of pregnancy. The reference
listed drug is Depo-Provera.
July 21
July 16
- FDA establishes a new Cancer Office and Program to improve
efficiency and consistency of cancer product reviews.
FDA
News.
July 15, 2004
- FDA approves the use of Aldara (imiquimod) topical cream for the
treatment of superficial basal cellcarcinoma (sBCC), a type of skin
cancer.
FDA
News.
July 7, 2004
- FDA approves Technetium (99m Tc) Fanolesomab, NeutroSpec (murine
monoclonal antibody to CD15)for the scintigraphic imaging of patients
with equivocal signs and symptoms of appendicitis who are five years
of age or older.
June 28, 2004
- FDA revises the Effexor (venlafaxine HCl) and Effexor XR (venlafaxine
HCl) labels to alert neuropsychiatric, obstetric and neonatology
healthcare professionals to two important safety issues.
MedWatch Safety Information.
June 24, 2004
- FDA approves first-time generic Levothyroxine Sodium for the
treatment of hypothyroidism.
June 23, 2004
- Serzone (nefazodone hydrochloride) - Healthcare professionals
encouraged to engage in a thorough risk-benefit analysis -- including
consideration of the risk of hepatic failure.
Serzone Safety Information.
June 22, 2004
- FDA and GlaxoSmithKline notify healthcare professionals of
revisions to the labeling for the following drug products:Paxil
(paroxetine hydrochloride) Tablets, Paxil CR (paroxetine
hydrochloride) Controlled-Release Tablets; Wellbutrin (bupropion
hydrochloride) Tablets, Wellbutrin SR (bupropion hydrochloride)
Sustained-Release Tablets, Wellbutrin XL (bupropion hydrochloride)
Extended-Release Tablets. These revisions alert healthcare
professionals that patients with major depressive disorder, both adult
and pediatric, may experience worsening of their depression and/or the
emergence of suicidal ideation and behavior (suicidality), whether or
not they are taking antidepressant medications.
Paxil
Safety Information.
Wellbutrin Safety Information.
June 21 , 2004
- FDA approves two applications for generic Metformin Hydrochloride
Extended-release Tablets, 500 mg as an oral antihyperglycemic agent.
June 16, 2004
- FDA approves four first-time adenosine injection products for
conversion from paroxysmal supraventricular tachycardia (PSVT) to
sinus rhythm.
June 10, 2004
- FDA approves 13 first-time generic ciprofloxacin tables for
antibiotic use, particularly as an anthrax prophylaxis agent.
June 9, 2004
- FDA approves first-time generic Ciprofloxacin Ophthalmic Solution
USP, 0.3% as an anti-infective.
- AstraZeneca revises the Crestor (rosuvastatin) label in EU in
response to spontaneous postmarketing adverse event reports. FDA
issues a public health advisory for Crestor emphasizing that the
changes to the European labeling have already been captured in the
FDA-approved label for Crestor at the time of its approval in August
2003. Physicians are advised to carefully read the product label and
follow recommendations to ensure the safe and effective use of
Crestor. Public Health Advisory.
June 7, 2004
- FDA approves Istalol (timolol maleate ophthalmic solution) 0.5%.
This drug is indicated for the treatment of elevated intraocular
pressure in patients with open-angle glaucoma or ocular hypertension.
- FDA approves Peginterferon alfa-2a co-packaged with ribavirin,
USP. Peginterferon alfa-2a, alone or in combination with Copegus, is
indicated for the treatment of adults with chronic hepatitis C virus
infection who have compensated liver disease and have not been
previously treated with interferon alpha.
- FDA warns against women using an unapproved drug, Domperidone, to
increase milk production.
FDA
News. Warning Letters.
June 1, 2004
- FDA approves first-time generic Metronidazole Topical Cream, 0.75%
for the treatment of inflammatory papules and pustules of rosacea.
- FDA approves first-time generic Itraconazole Capsules, 100 mg. as
an antifungal.
May 19, 2004
- FDA approves Vidaza for treatment of patients with certain
myelodysplastic syndrome subtypes.
FDA
News.
- FDA approves Gemzar in combination with paclitaxel for the
first-line treatment of patients with metastatic breast cancer.
- FDA approves Taxotere (docetaxel) injection in combination with
prednisone for the treatment of patients with advanced metastatic
prostate cancer. This is the first drug approved for hormone
refractory prostate cancer that has shown a survival benefit.
FDA
News.
- FDA approves Avelox (moxifloxacin hydrochloride) Tablets and I.V.
to treat community-acquired pneumonia caused by multi-drug resistant
Streptococcus pneumoniae.
May 14, 2004
- FDA and McNeil alert healthcare professionals that one
manufacturing lot (Lot # JAM108, exp 1/06) of Children's Motrin
(ibuprofen) Grape Chewable Tablets may mistakenly contain Tylenol
8-Hour extended release (acetaminophen) Geltabs. MedWatch Safety Info.
- FDA approves three first-time generics for fluticasone propionate
cream, and two for fluticasone propionate ointment.
- FDA approves four first-time generics for Ofloxacin Ophthalmic
Solution for the treatment of infections caused by susceptible strains
of bacteria in conjunctivitis and corneal ulcers.
May 12, 2004
- FDA and Bristol-Myers Squibb notify healthcare professionals of
revisions to the Clinical Pharmacology and Precautions sections of the
Desyrel labeling. In vitro drug metabolism studies suggest that there
is a potential for drug interactions when trazodone is given with the
CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir.
MedWatch Safety Info.
May 7, 2004
- FDA acknowledges that it has issued a “Not Approvable” letter to
the sponsor of an application to make the Plan B emergency
contraception product available without a prescription.
Plan B Information Page.
May 6, 2004
- FDA announces the display of a proposed rule discussing how FDA
proposes to assign a lead center with responsibility for premarket
review and regulation of a combination product.
FDA
Talk Paper.
- FDA approves Vitrase (hyaluronidase for injection). Vitrase is an
injectable drug approved as an adjunct to (in combination with) other
injected drugs to increase their absorption and dispersion. FDA
Talk Paper.
May 5, 2004
- Savient Pharmaceuticals, Inc. notifies healthcare professionals of
an important drug interaction between Oxandrin, a synthetic derivative
of testosterone, and the oral anticoagulant warfarin for systemic
anticoagulation.
MedWatch Safety Information.
May 4, 2004
- FDA announces the availability of three draft guidances to help
industry develop risk management activities.
FDA
News and Guidances.
April 29, 2004
- FDA approves first-time generic gabapentin 100 mg, 300 mg, and 400
mg, and tentatively approves 600 mg and 800 mg. Gabapentin is used for
adjunctive therapy in the treatment of partial seizures with and
without secondary generalization in adults with epilepsy. The
innovator is Neurontin Tablets 600 mg and 800 mg.
April 28, 2004
- FDA updates the label for Zelnorm with new risk information.
Zelnorm is used to treat women with irritable bowel syndrome whose
primary bowel symptom is constipation.
Zelnorm Information Page.
April 27, 2004
- FDA requires pancreatic extract manufacturers to submit marketing
applications.
FDA
Press Release.
April 26, 2004
- FDA approves first-time generic Terbutaline Sulfate Injection for
the prevention and reversal of bronchospasm. The innovator is Brethine
Injection.
April 21, 2004
- FDA approves Apokyn (apomorphine) for treating Parkinson's
patients during episodes of "hypomobility," so-called "off periods" in
which the patient becomes immobile or unable to perform activities of
daily living.
FDA
Talk Paper.
April 16, 2004
- FDA approves generic Diazepam Injection USP, 5 mg/ml for relief of
skeletal muscle spasms and treatment of anxiety disorders.
- FDA warns consumers not to purchase or consume products marketed
as "street drug alternatives" by Cytotec Solutions, Inc., of Tampa,
Fla.
MedWatch Safety Alert.
April 13, 2004
- FDA requests that a warning be added to the prescribing
information for all atypical antipsychotics regarding the risk of
hyperglycemia and diabetes.
MedWatch Safety Info.
April 9, 2004
- Janssen Pharmaceutica notifies healthcare professionals of an
expanded recall of Duragesic 75 mcg/h., originally recalled in
February 2004.
MedWatch Safety Info.
April 8, 2004
- FDA approves Nasacort HFA (triamcinolone acetonide) Nasal Aerosol
for allergic rhinitis. This is the first HFA nasal steroid.
- FDA approves first-time generics Ribasphere (Ribavirin Capsules)
and Ribavirin Capsules for the treatment of chronic hepatitis C. The
innovator is Rebetol Capsules.
March 31, 2004
- FDA approves first-time generic Quinaretic Tablets (quinapril
hydrochloride and hydrochlorothiazide tablets) for the treatment of
hypertension. The innovator is Accuretic Tablets of Pfizer
Pharmaceuticals Ltd.
March 29, 2004
- Propharma, Inc., Miami, Florida issued a recall of Major
Twice-A-Day 12 Hour Nasal Spray (Lot #K4496, Exp 10/06) because the
lot was contaminated with Burkholderia cepacia bacteria.
MedWatch Safety Info.
- FDA enhances safeguards for consumers who may have special
sensitivities to certain commonly used over-the-counter drug
ingredients.
FDA
News.
March 24, 2004
- FDA approves two first-time generic oxycodone hydrochloride
products for the management of moderate to severe pain.
FDA
Statement.
March 22, 2004
- FDA requests warning statement in labeling for certain
antidepressants to encourage close observation for worsening
depression or the emergence of suicidality.
FDA
Talk Paper.
Antidepressant Page.
- FDA and Lilly notify healthcare professionals of revision to the
WARNINGS section of labeling, describing the increased risk of
hyperglycemia and diabetes in patients taking Zyprexa.
MedWatch Safety Info.
March 17, 2004
- FDA approves first-time generic Desferal for Injection for the
treatment of acute iron intoxication or chronic iron overload.
- FDA approves first-time generic Naproxen Sodium and
Pseudoephedrine Hydrochloride Extended-release Tablets for the
temporary relief of these cold, sinus and flu symptoms: sinus
pressure, minor body aches and pains, headache, fever, nasal and sinus
congestion.
March 8, 2004
- FDA approves Sensipar (cinacalcet), the first in a new class of
drugs to treat hyperparathyroidism associated with renal failure and
in patients with parathyroid cancer.
- FDA issues recommendations on the development of drugs to treat
the side effects of vaccination against smallpox.
FDA
News.
Draft Guidance
March 3, 2004
- FDA launches Drugs@FDA, a
new, easy-to-use web site to help consumers and health professionals
find information about FDA-approved drug products.
FDA
News
Drugs@FDA
March 2, 2004
- FDA announces that it will provide more information to the public
to help generic drug applicants determine if they are eligible for
180-day marketing exclusivity for their products.
FDA
News
February 26, 2004
- FDA approves Avastin (bevacizumab) as a first-line treatment for
patients with colorectal cancer that has spread to other parts of the
body. Avastin Information
Page
February 25, 2004
- FDA issues a rule requiring bar codes on drug and blood products
to reduce the risk of medication errors.
FDA
Information Page.
February 20, 2004
- Janssen Pharmaceutica and FDA notify healthcare professionals of a
Class I recall of Duragesic 75 mcg/h. Only Control Number 0327192
(expiration October 2005) is subject to this recall.
MedWatch Safety Info.
February 11, 2004
- FDA approves 13 first-time generics for Lotensin (Benazepril
Tablets) or Lotensin HCT (Benazepril and Hydrochlorothiazide Tablets).
These products are used to treat hypertension, and should
significantly reduce the cost to treat this disease.
- FDA approves first-time generic Mercaptopurine Tablets for
remission induction and maintenance therapy of acute lymphatic
leukemia.
February 10, 2004
- FDA and Johnson and Johnson Co. are warning the public about an
overseas Internet site selling counterfeit contraceptive patches that
contain no active ingredients.
MedWatch Safety Information
- FDA updates hormone therapy (estrogen and combination estrogen and
progestin products) information for postmenopausal women.
Estrogens
Information Page.
February 6, 2004
-
FDA
approves Oxycodone Hydrochloride (non combination product)
February 5, 2004
- FDA approves first-time generic TriLyte (Polyethylene Glycol 3350,
Potassium Chloride, Sodium Bicarbonate and Sodium Chloride for Oral
Solution).
- FDA approves Alimta (pemetrexed disodium) for use in combination
with cisplatin for the treatment of patients with malignant pleural
mesothelioma.
FDA
News
February 2, 2004
- FDA approves Spiriva HandiHaler (tiotropium bromide inhalation
powder) for the long-term, once-daily, maintenance treatment of
bronchospasm associated with chronic obstructive.
- Boehringer Ingelheim and FDA notify healthcare professionals of
new safety information added to the WARNINGS and Boxed Warning for
Viramune (nevirapine).
MedWatch Safety Information
January 29, 2004
- FDA approves first-time generic over-the-counter loratadine and
pseudoephedrine sulfate extended-release tablets, 5 mg/120 mg (12-hour
formulation).
January 22, 2004
- FDA launches a consumer campaign on the safe use of OTC pain
reliever and fever reducer products.
FDA Information Page.
- U.S. General Accounting Office releases its report, "Prescription
Drugs: OxyContin Abuse and Diversion and Efforts to Address the
Problem."
GAO Report.
January 21, 2004
- FDA approves first-time generic Ibuprofen Chewable Tablets for use
in children to temporarily reduce minor aches and pains due to the
common cold, flu, sore throat, headache, and toothache.
January 15, 2004
- FDA approves first-time generic hydrocortisone butyrate solution
01%, topical administration, for relief of the inflammatory and
pruritic manifestations of seborrheic dermatoses.
January 13, 2004
- FDA approves Eloxatin (oxaliplatin for injection) for the initial
treatment of advanced colon cancer based on improved survival.
Eloxatin Label.
January 2, 2004
- New preclinical safety data suggest that Tamiflu is not indicated
for either treatment or prophylaxis of influenza in infants less than
one year of age.
MedWatch Safety Info.
News Items 2008
News Items 2007
News Items 2006
News Items 2005
News Items 2003
News Items 2002
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Date created: February 2, 2004; Last updated: January2, 2008 |
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