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FDA News Articles

FDA Committee Favors Peginesatide

Stephan Cho 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

Stephan Cho 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

Jody A. Charnow 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

Jody A. Charnow 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

Delicia Honen Yard 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

Delicia Honen Yard 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

Delicia Honen Yard 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

Delicia Honen Yard 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

Delicia Honen Yard 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

Delicia Honen Yard 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.

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