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CDER News Items 2005
December
28, 2005
December 21, 2005
- FDA tentatively approves Stavudine for use in pediatric patients
with HIV.
FDA
News.
December 20, 2005
- FDA approves Nexavar (sorafenib) for the treatment of patients
with advanced renal cell carcinoma.
FDA
News.
December 19, 2005
- Palatin Technologies and the FDA have agreed on the immediate
suspension of sales and marketing of NeutroSpec [Technetium (99m Tc)
fanolesomab] in the U.S. due to reports of serious and
life-threatening cardiopulmonary events following the administration
of the drug.
NeutroSpec Info.
December 13, 2005
- FDA and Bedford Laboratories announce a voluntarily recall of one
lot of Methotrexate for Injection.
MedWatch Safety Info.
December 8, 2005
- FDA issues an Alert and Patient and Healthcare Professional Sheets
for Clarithromycin (marketed as Biaxin).
Information
December 8, 2005
December 6, 2005
- FDA advises consumers not to use Miracle II Neutralizer and
Miracle II Neutralizer Gel products manufactured by Tedco, Inc.,
because the products are bacterially contaminated and have not been
proven to be safe and effective.
MedWatch Safety Info.
December 5, 2005
- FDA approves first-time generic Ribavirin tablets, used in
combination with peginterferon alfa-2a for the treatment of adults
with chronic hepatitis C virus infection. The reference listed drug is
Copegus Tablets.
December 2, 2005
- Mallinckrodt, Palatin Technologies and FDA notify healthcare
professionals of postmarketing reports of serious and life-threatening
cardiopulmonary events following the administration of NeutroSpec
[Technetium (99m Tc) fanolesomab].
MedWatch Safety Info.
December 1, 2005
- Amgen, Ortho Biotech and FDA notify healthcare professionals of
revision to the prescribing information for Epogen and Procrit.
MedWatch Safety Info.
- Amgen and FDA notify healthcare professionals of revisions to the
prescribing information for Aranesp.
MedWatch Safety Info.
November 30, 2005
November 30, 2005
- MBI Distributing, Inc., an over-the-counter drug manufacturer of
eye drops and other products, will cease manufacturing and
distributing drugs until it corrects manufacturing deficiencies and
other violations.
MedWatch Safety Information
November 29, 2005
November 27, 2005
- Novartis Ophthalmics and FDA notify healthcare professionals and
patients of a voluntary recall due to a lack of sterility assurance of
seven lots of two products, GenTeal Gel and GenTeal GelDrops.
MedWatch Safety Info.
November 22, 2005
- Boehringer Ingelheim and FDA notify healthcare professionals of
revisions to Precautions and Adverse Reactions sections of the
prescribing information for Flomax.
MedWatch Safety Info
November 18, 2005
November 17, 2005
November 14, 2005
- FDA approves nine first-time generic Azithromycin Tablets to treat
bacterial infections. The reference listed drug is Zithromax.
November 10, 2005
- Biogen Idec and FDA notify healthcare professionals that Amevive
should not be administered to patients infected with HIV.
MedWatch Safety Info.
- FDA notifies healthcare professionals of the potential for
life-threatening falsely elevated glucose readings in patients who
have received parenteral products containing maltose or galactose, or
oral xylose, and are subsequently tested using glucose dehydrogenase
pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems.
MedWatch Safety Info.
- FDA and FTC issue Warning Letters to marketers of unapproved
"alternative hormone therapies."
FDA
News.
- FDA approves updated labeling for the Ortho Evra contraceptive
patch to warn healthcare providers and patients that this product
exposes women to higher levels of estrogen than most birth control
pills.
FDA News.
November 9, 2005
- FDA approves first-time generic Sodium Bicarbonate Injection to
treat metabolic acidosis, barbiturate intoxication, salicylate
and methyl alcohol poisoning, and severe diarrhea accompanied by lost
of bicarbonate.
- FDA approves Exjade (deferasirox), an oral iron chelator developed
to treat chronic iron overload due to multiple blood transfusions.
FDA
News.
November 4, 2005
- FDA tentatively approves first-time generic Lamivudine Oral
Solution. This child-friendly product is indicated for use in
pediatric patients with HIV.
FDA
News.
- Ligand Pharmaceuticals Inc. and FDA notify healthcare
professionals of revisions to Avinza labeling to highlight and
strengthen the warning that patients should not consume alcohol while
taking Avinza.
MedWatch Safety Info.
November 2, 2005
- FDA approves Tarceva in combination with gemcitabine for
first-line treatment of patients with locally advanced, unresectable
or metastatic pancreatic cancer.
October 31, 2005
- FDA approves Arranon (nelarabine) to treat adults and children
with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell
lymphoblastic lymphoma (T-LBL)
FDA
News.
October 28, 2005
- FDA approves first-time generic Glipizide and Metformin
Hydrochloride Tablets for glycemic control in patients with type II
diabetes. The reference listed drug is Metaglip Tablets.
- Accutane iPLEDGE Update: To allow more time for registration and
activation, the implementation dates of the iPLEDGE program have been
revised. Updated Public
Health Advisory.
October 24, 2005
- FDA approves first-time generic Ramipril Capsules as an ACE
inhibitor to reduce risk of myocardial infarction, stroke, and death
from cardiovascular causes and treatment of hypertension. The
reference listed drug is Altace.
- FDA notifies healthcare professionals who prescribe Cylert or any
of its generics to transition their patients to an alternative
therapy. Cylert
Safety Sheet
October 17, 2005
- Eli Lilly and FDA notify healthcare professionals of revision to
the Precautions/Hepatotoxicity section of the prescribing information
for Cymbalta (duloxetine hydrochloride)
MedWatch Safety Info.
October 6, 2005
- FDA approves first-time generic Glimepiride Tablets to be used
alone or in conjunction with other oral hypoglycemics to lower blood
glucose levels for those with non-insulin dependent diabetes mellitus
or in combination with insulin for those with insulin dependent
diabetes mellitus.
September 29, 2005
- FDA issues a Public Health Advisory on Strattera for Attention
Deficit Disorder.
More Information
September 27, 2005
- Healthcare professionals are notified of changes to prescribing
information describing an epidemiological study reporting an increase
in risk of overall major congenital malformations for paroxetine as
compared to other antidepressants.
Medwatch Safety Info.
September 23, 2005
September 19, 2005
- FDA approves first pediatric generic AIDS drug for U.S. marketing.
FDA
News
September 17, 2005
- Recall: Injectable Products made by Central Admixture
Pharmacy Service (CAPS) of Lanham, Maryland -
Recall Information
September 15, 2005
- FDA Proposes Rule on Current Good Manufacturing Practices for
Positron Emission Tomography (PET) Drugs.
More Information
September 13, 2005
- FDA approves first-time generic Leflunomide Tablets, 10 mg and 20
mg for the treatment of active rheumatoid arthritis.
September 9, 2005
- FDA tentatively approves generic Zidovudine Oral Solution, for
HIV/AIDS treatment in association with the President's Emergency Plan
for AIDS Relief.
FDA
News
August 31, 2005
- Genentech and FDA notify healthcare professionals of updated
cardiotoxicity information related to the use of Herceptin (trastuzumab).
MedWatch Safety Info.
August 29, 2005
- Custom RX Compounding Pharmacy and FDA announce a nationwide
recall of Trypan Blue 0.06% Ophthalmic Solution.
MedWatch Safety Info
August 26, 2005
August 12, 2005
- FDA announces a strengthened risk management program to enhance
safe use of Isotretinoin (Accutane) for treating severe acne.
Accutane Information.
August 3, 2005
- FDA approves first-time generic Hydrocortisone Butyrate Cream as a
topical corticosteroid. The reference listed drug is Locoid Cream.
- FDA approves first-time generic Clonazepam Orally Disintegrating
Tablets. The reference listed drug is Klonopin Rapidly Disintegrating
Tablets.
July 20, 2005
- Four reported deaths prompt FDA warning about Mifeprex.
FDA
News. Mifeprex
Info.
- Genentech and FDA revise the labeling and Patient Information
Sheet for Raptiva (efalizumab), indicated for the treatment of adult
patients with chronic moderate to severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.
MedWatch Safety Info
July 19, 2005
- Scios and FDA notify healthcare professionals about the
recommendations of an expert panel of cardiology and heart failure
clinicians with regard to Natrecor (nesiritide).
MedWatch Safety Info
July 15, 2005
July 13, 2005
- FDA asks Purdue Pharma to withdraw Palladone for safety reasons.
FDA
News.
Palladone Information
- FDA tentatively approves first-time generic Zidovudine under the
President’s Emergency Plan for AIDS Relief.
FDA
News
July 12, 2005
- FDA approves first-time generic Alclometasone Dipropionate Cream
USP, 0.05% for relief of inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses. The reference listed drug is
Aclovate.
July 8, 2005
- As promised in our Public
Health Advisory of 6/30/2005, FDA has updated the safety sheets
for the other antidepressant drugs.
Drugs with
safety sheets
- Janssen and FDA notify healthcare professionals of changes to the
prescribing information for Duragesic (fentanyl transdermal system).
MedWatch Safety Info
- FDA updates labeling for Viagra, Cialis and Levitra for rare
post-marketing reports of eye problems.
FDA
Statement
July 7, 2005
- FDA tentatively approves first-time generic Lamivudine and
Zidovudine under the President’s Emergency Plan for AIDS Relief.
FDA
News
July 1, 2005
- FDA reviews data for antidepressant use in adults.
FDA
Talk Paper Public
Health Advisory
- FDA approves first-time generic Desmopressin Acetate Tablets, 0.1
mg and 0.2 mg to treat central diabetes insipidus and primary
nocturnal enuresis.
- FDA tentatively approves first-time generic Stavudine under the
President’s Emergency Plan for AIDS Relief.
FDA
News
- FDA warns consumers not to take Liqiang 4 Dietary Supplement
Capsules because they contain glyburide, a drug that could have
serious, life-threatening consequences in some people.
FDA
Talk Paper
June 29, 2005
- The Office of Drug Safety announces a nationwide search for a new
director of drug safety with the Food and Drug Administration.
FDA
News
Position Announcement
June 24, 2005
- FDA tentatively approves first-time generic Efavirenz under the
President’s Emergency Plan for AIDS Relief.
FDA
News
June 23, 2005
- FDA approves Aptivus (tipranavir) capsules, an HIV protease
inhibitor, to be given with ritonavir for treatment of HIV-1 infected
adults.
FDA
News
Label
[PDF]
- FDA approves BiDil, a drug for the treatment of heart failure for
black patients.
FDA
News
Label
[PDF]
June 20, 2005
- FDA tentatively approves first-time generic Nevirapine under the
President’s Emergency Plan for AIDS Relief.
FDA
News
June 17, 2005
- AstraZeneca and FDA notify healthcare professionals of new
approved labeling for Iressa that states the medicine should be used
only in cancer patients who have already taken the medicine and whose
doctor believes it is helping them.
Iressa Information
June 16, 2005
- FDA approves Alinia (nitazoxanide) for treatment of diarrhea
caused by Cryptosporidium parvum in non-HIV infected patients 12 years
of age and older.
Label (PDF)
June 15, 2005
- FDA issues supplemental request letters to sponsors of all
non-steroidal anti-inflammatory drugs (NSAID) requesting that they
make labeling changes to their products.
Supplemental
Request Letters.
- FDA's Office of Generic Drugs grants a tentative approval for
Lamivudine Tablets, indicated for use in combination with other
antiretroviral agents for the treatment of HIV-l infection.
More Information.
June 10, 2005
- Bristol-Myers Squibb and FDA notify healthcare professionals of
revisions to the prescribing information for Sustiva (efavirenz),
indicated in the treatment of HIV-1 infection.
MedWatch Safety Info.
- FDA approves first-time generic Carbilev (Carbidopa/Levodopa) to
treat Parkinson's Disease. The reference listed drug is Sinemet
Tablets.
June 3, 2005
- McNeil Specialty Pharmaceuticals and FDA announce a nationwide
recall of all lots and all flavors of Children's Tylenol Meltaways 80
mg, Children's Tylenol SoftChews 80mg, and Junior Tylenol Meltaways
160mg.
MedWatch Safety Info.
June 1, 2005
- FDA advises consumers about recalled drugs from Able Laboratories.
FDA
News.
May 31, 2005
- FDA approves first-time generic Foscarnet Sodium for the treatment
of cytomegalovirus retinitis in patients with acquired
immunodeficiency syndrome (AIDS). The reference listed drug is
Foscavir.
May 24, 2005
- Serono and FDA notify healthcare professionals of revisions to the
prescribing information for Novantrone (mitoxantrone), indicated for
treatment of multiple sclerosis.
MedWatch Safety Info.
May 19, 2005
- Scios and FDA notify healthcare professionals of revisions to the
prescribing information for Natrecor (nesiritide), indicated for
patients with acutely decompensated congestive heart failure.
MedWatch Safety Info.
May 18, 2005
- Novartis and FDA notify dental healthcare professionals of
revisions to the prescribing information to describe the occurence of
osteonecrosis of the jaw observed in cancer patients receiving
treatment with intravenous bisphosphonates, Aredia (pamidronate
disodium) and Zometa (zoledronic acid).
MedWatch Safety Info.
- FDA releases "Combating Counterfeit Drugs: A Report of the Food
and Drug Administration -- Annual Update."
FDA
Talk Paper
The Report
May 11, 2005
- FDA warns the public about the sale of counterfeit Lipitor,
Viagra, and an unapproved product promoted as "generic Evista" at
pharmacies in Mexican border towns.
FDA
Talk Paper.
May 5, 2005
- FDA approves Requip (ropinirole) to treat moderate to severe
Restless Legs Syndrome (RLS).
FDA
Talk Paper.
April 18, 2005
- Famotidine Injection - Recall of one lot of Famotidine Injection,
20 mg/2 mL due to a lack of sterility assurance.
MedWatch Safety Info.
- Eli Lilly and FDA notify healthcare professionals of the stopping
of enrollment in a randomized, double-blind, placebo-controlled trial
of Xigris in pediatric patients with severe sepsis. Xigris is not
indicated for use in pediatric severe sepsis.
MedWatch Safety Info.
April 14, 2005
- FDA approves first-time generic Niacin Extended-Release to treat
hypercholesterolemia. The reference listed drug is Niaspan.
- FDA approves first-time generic Fexofenadine Hydrochloride and
Pseudoephedrine Hydrochloride Extended-release Tablets as an
antihistamine/decongestant. The reference listed drug is Allegra-D 12
Hour.
April 11, 2005
- FDA issues a Public Health Advisory for antipsychotic drugs used
for treatment of behavioral disorders in elderly patients.
FDA
Talk Paper.
Public Health Advisory.
- FDA approves new drug Retisert (fluocinolone acetonide
intravitreal implant) 0.59 mg. to treat chronic non-infectious uveitis
affecting the posterior segment of the eye.
April 7, 2005
April 1, 2005
- Ortho-McNeil Neurologics modifies the Precautions section of the
label for Reminyl, approved only for the treatment of mild to moderate
Alzheimer’s Disease.
MedWatch Safety Info.
March 31, 2005
- • March 31. FDA announces that albuterol metered-dose inhalers (MDIs)
using chlorofluorocarbon (CFC) propellants must no longer be produced,
marketed or sold in the United States after December 31, 2008.
FDA
Talk Paper.
March 28, 2005
- FDA approves first-time generic Octreotide Acetate Injection to
reduce blood levels of growth hormone and IGF-1 in acromegaly
patients. The reference listed drug is Sandostatin.
March 25, 2005
- Novartis and FDA notify healthcare professionals of revisions to
the Zometa (zoledronic acid) label to reflect new safety information
on management of patients with advanced cancer and renal impairment.
MedWatch Safety Info.
March 24, 2005
- FDA issues three final guidance documents to help develop new ways
and improve methods to assess and monitor the risks associated with
drugs and biological products in clinical development and general use.
FDA
News and Guidances.
- FDA reports on 2004 accomplishments.
FDA
Talk Paper.
- Wyeth Pharmaceuticals announced that Trecator-SC (ethionamide
tablets, USP) Sugar-Coated Tablets have been reformulated to
film-coated tablets and renamed Trecator.
MedWatch Safety Alert.
March 22, 2005
March 16, 2005
- FDA approves a new indication for Temodar (temozolomide). The drug
can extend the lives of adult patients newly diagnosed with
glioblastoma multiforme, the most common form of malignant brain
cancer.
FDA
Talk Paper.
- FDA and Biogen notify healthcare professionals of revisions to the
labeling and Medication Guide for Avonex. Severe hepatic injury,
including cases of hepatic failure, has been reported in patients
taking the drug.
MedWatch Safety Info.
- FDA notifies healthcare professionals to revisions of the Xigris
labeling, describing higher all-cause mortality in the Xigris group
compared to placebo in a subset of sepsis patients (those with
single-organ dysfunction and recent surgery), based on analyses of two
clinical trial databases.
MedWatch Safety Info.
March 14, 2005
March 10, 2005
- FDA issues a Public Health Advisory informing health care
providers of safety concerns associated with the use of two eczema
drugs, Elidel and Protopic. FDA.
Public Health Advisory.
FDA
Talk Paper.
March 4, 2005
- U.S. Marshals seize lots of GlaxoSmithKline's Paxil CR and
Avandamet tablets because of continuing good manufacturing practice
violations.
FDA
News.
MedWatch Safety Info.
March 3, 2005
- FDA approves first-time generic Miconazole 3 (Miconazole Nitrate
Vaginal Cream, 4%) to treat vaginal yeast infections, and for the
relief of external itching and irritation due to a vaginal yeast
infection. The reference listed drug is Monistat 3.
March 2, 2005
February 28, 2005
February 18, 2005
February 15, 2005
February 14, 2005
February 9, 2005
- FDA issues Public Health Advisory for Adderall and Adderall XR.
Information and
Public
Health Advisory.
- Shire and FDA notify healthcare professionals about changes to the
prescribing information for Agrylin (anagrelide hydrochloride), a
medication approved for the treatment of thrombocythemia.
MedWatch Safety Info.
February 8, 2005
- Eli Lilly and FDA notify healthcare professionals on reports of
medication dispensing or prescribing errors between ZyPREXA (olanzapine)
and the antihistamine ZYRTEC (cetirizine HCI).
MedWatch Safety Info
January 28, 2005
- FDA approves first-time generic Fentanyl Transdermal System for
the management of chronic pain in patients who require continuous
opioid analgesia for pain that cannot be managed by lesser means such
as acetaminophen-opioid combinations, non-steroidal analgesics or PRN
dosing with short-acting opioids.
FDA
Talk Paper.
January 27, 2005
- FDA approves first-time generic Desmopressin Acetate Nasal
Solution for for the management of primary nocturnal enuresis and
central cranial diabetes insipidus. The reference listed drug is DDAVP
Nasal Spray.
January 19, 2005
January 14, 2005
- FDA and Amgen notify healthcare professionals of revisions to the
labeling for Aranesp. This information alerts physicians to the
adverse effects observed with other products in this class in
association with off-label dosing strategies.
MedWatch Safety Information
January 12, 2005
- FDA approves generic over-the-counter ThyroShield (Potassium
Iodide Oral Solution) as a thyroid blocking agent in radiation
emergencies.
January 10, 2005
- FDA and Wyeth notify pharmacists and physicians of a new
Medication Guide for Cordarone (amiodarone hydrochloride tablets).
MedWatch Safety Information
January 7, 2005
- FDA approves Abraxane for treatment of breast cancer after failure
of combination chemotherapy for metastatic disease or relapse within 6
months of adjuvant chemotherapy. Prior therapy should have included an
anthracycline unless clinically contraindicated.
Abraxane Label
January 6, 2005
- FDA and Genentech notify healthcare professionals of revisions to
the Avastin labeling. Arterial thromboembolic events occurred at
a higher incidence in patients receiving Avastin in combination with
chemotherapy as compared to those receiving chemotherapy alone.
MedWatch Safety Info
January 3, 2005
- FDA approves first-time generic Ciclopirox Olamine Cream as an
antifungal cream. The reference listed drug is Loprox Cream.
News Items 2008
News Items 2007
News Items 2006
News
Items 2004
News Items 2003
News Items
2002
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Date created: January 4, 2006; Last updated: January, 2008
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