 |
Previous News Items, 2004
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.
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.
Previous News Items 2003
Back to Top 
Back to CDER Home
Date updated: October 29, 2004 |
|
