FDA News

FDA Committee Favors Peginesatide

December 15, 2011

The FDA's Oncologic Drugs Advisory Committee, in a 15 to 1 vote, has agreed that peginesatide demonstrates a favorable benefit/risk profile for use in treatment of dialysis patients with anemia resulting from chronic kidney disease (CKD).
 

Long-Acting Drug for Post-Op Pain Approved

November 01, 2011

The FDA has approved Exparel (bupivacaine), a single-dose injection that provides post-surgical pain relief for up to 72 hours.
 

Drug Cleared for Treating ADT-Related Bone Loss in Prostate Cancer Patients

September 19, 2011

The FDA has approved denosumab (Prolia) as a treatment to increase bone mass in prostate cancer patients at high risk for fracture undergoing androgen deprivation therapy (ADT) and women with breast cancer at high risk for fracture who are receiving aromatase inhibitor therapy.
 

FDA Issues Surgical Mesh Safety Alert

August 01, 2011

The FDA recently issued a safety alert regarding placement of surgical mesh as a treatment for pelvic organ prolapse (POP).
 

New Indication Okayed for Chronic Hepatitis B Drug

November 16, 2010

Bristol-Myers Squibb of Princeton, N.J., has received FDA approval to market Baraclude (entecavir) as a treatment for chronic hepatitis B (CHB) patients with evidence of decompensated liver disease.
 

New Oral Anticoagulant Cleared for Reducing Stroke Risk

November 16, 2010

Pradaxa (dabigatran etexilate) capsules have received FDA approval for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).
 

FDA Takes On Unapproved Single-Ingredient Colchicine

November 16, 2010

The FDA has ordered a halt to the marketing of unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of familial Mediterranean fever.
 

Brand Name for Epoprostenol for Injection Okayed

October 29, 2010

The FDA has approved the brand name for commercially available Veletri (epoprostenol for injection) for pulmonary arterial hypertension (PAH).
 

Withdrawal of Approval for Midodrine Proposed

October 29, 2010

The FDA has proposed withdrawing approval of midodrine, a drug used to treat orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the medication have not been done, the agency announced.
 

Drug for Chronic Refractory Gout Approved

October 29, 2010

Savient Pharmaceuticals, Inc., of East Brunswick, N.J., has received FDA clearance to market Krystexxa (pegloticase) as a treatment for chronic gout in adult patients refractory to conventional treatment.
 

Ultra-Fine Pen Needle for Diabetics Debuts

July 27, 2010

Becton, Dickinson and Company (BD), based in Franklin Lakes, N.J., has launched the BD Ultrafine Nano, which the company says is the world's smallest pen needle.
 

Over the Counter Pain Relief Patches Introduced

July 27, 2010

Hisamitsu Pharmaceutical, which has U.S. headquarters in Torrance, Calif., has introduced two over-the-counter pain relief patches to the American market, the Salonpas Pain Relief Patch and Salonpas Arthritis Pain patch.
 

Marketing Clearance Granted to New Glucose Test Strips

July 27, 2010

Abbott has received FDA clearance to market FreeStyle Lite glucose test strips. The test strips minimize interference during blood glucose testing and are designed to offer a better experience, Abbott says.
 

Imaging Agent for Bladder Cancer Okayed

July 27, 2010

The FDA has approved Cysview (hexaminolevulinate HCl), an optical imaging agent indicated for use in the cystoscopic detection of non-muscle-invasive papillary bladder cancer in patients suspected or known to have lesions on the basis of prior cystoscopy.
 

FDA Mulls Application for Prostate Imaging Device

July 27, 2010

ProUroCare Medical, Inc., of Minneapolis, Minn., has filed a de novo application with the FDA seeking marketing clearance for its prostate mechanical imaging (PMI) device (ProUroScan).
 

Intranasal Ketorolac Cleared for Pain Management

June 14, 2010

A novel prescription intranasal formulation of ketorolac tromehtamine (Sprix Nasal Spray), a non-steroidal anti-inflammatory drug, has been approved for the short-term management of acute moderate to moderately severe pain that requires analgesia at the opioid level.
 

GnRH Agonist Safety Is Under Review

June 14, 2010

The FDA is conducting a safety review of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs used primarily as a treatment for prostate cancer.
 

Home Hemodialysis Safety Device Approved

June 14, 2010

The Redsense safety device, which is designed to detect venous needle displacement during hemodialysis (HD), has received FDA approval for home/self use during home HD, according to the device's manufacturer, Redsense Medical.
 

Company Introduces Its Novel Male Sling for SUI

June 14, 2010

San Francisco-based Coloplast has announced the debut of a new sling for treating male stress urinary incontinence (SUI).
 

Lower Dosage Strength Sirolimus Tablets Available

June 14, 2010

A lower dosage strength sirolimus (Rapamune) tablet is now commercially available, according to the drug's maker, Pfizer Inc., of New York.
 
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A primary care doctor referred a patient with an elevated PSA to a urologist. After a negative prostate biopsy, the doctor did not regularly conduct follow-up PSA testing, and the patient eventually died from prostate cancer.

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