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U.S. Department of Health and Human Services

Drugs

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Postmarket Drug Safety Evaluation Summaries Completed from July 2013 through September 2013

 

New Molecular Entities and Biological Products   

Product Name: Trade
(Active Ingredient)
NDA/BLA Number
Approval Date
Major Indication(s)Summary of Evaluation FindingActions Taken and Ongoing Surveillance Activities

Kedbumin (Albumin (Human))


BLA 125384

June 3, 2011
 

Treatment of: hypovolemia; hypoalbuminemia; Ovarian Hyperstimulation Syndrome (OHSS); Adult Respiratory Distress Syndrome (ARDS); burns; hemodialysis patients undergoing long term dialysis or who cannot tolerate substantial volumes of salt solution;
prevention of central volume depletion after paracentesis due to cirrhotic ascites;
in cardiopulmonary bypass as part of the priming fluids. 

No new safety concerns were identified.

No regulatory action required at this time.

Xarelto
(Rivaroxaban) 

 

NDA 022406 

 

July 1, 2011 

For the reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

For the treatment of deep vein thrombosis (DVT).


For the treatment of pulmonary embolism (PE).


For the reduction in the risk of recurrence of deep vein thrombosis and of pulmonary embolism following initial 6 months treatment for DVT and/or PE.

Adverse event reports of thrombocytopenia and venous thromboembolic events were identified.

FDA is continuing to evaluate thrombocytopenia and thromboembolic events to determine if regulatory action is required.

Zytiga
(Abiraterone)

 

NDA 202379

 

April 28, 2011 

For the treatment of patients with metastatic castration-resistant prostate cancer in combination with prednisone.

Adverse event reports of pneumonitis, pulmonary embolism and rhabdomyolysis events were identified.

FDA is continuing to evaluate pneumonitis, pulmonary embolism and rhabdomyolysis events to determine if regulatory action is required.

 

All Other Products   

Product Name: Trade
(Active Ingredient
NDA/BLA Number
Approval Date
Major Indication(s)Summary of Evaluation FindingsActions Taken and Ongoing Surveillance Activities

Actoplus Met XR
(Pioglitazone HCl and metformin HCl) extended-release

 

NDA 022024

 

May 12, 2009
 

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with pioglitazone and metformin or who have inadequate glycemic control on pioglitazone alone or metformin alone.

No new safety concerns were identified.

No regulatory actions required at this time.

Caldolor
(Ibuprofen) injection

 

NDA 022348

 

June 11, 2009
 

For the management of:
  - mild to moderate pain in adults 

  - moderate to severe pain in adults as an adjunct to opioid analgesics.

 

For the reduction of fever in adults. 

Adverse event reports of infusion-site reactions were identified.

FDA is continuing to evaluate infusion-site reactions to determine if regulatory action is required.

Combivent Respimat
(Albuterol sulfate / ipratropium bromide)

 

NDA 021747

 

October 7, 2011

For use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

No new safety concerns were identified.

No regulatory actions required at this time.

Cycloset
(Bromocriptine mesylate)

 

NDA 020866

 

May 5, 2009 

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

No new safety concerns were identified.
 

No regulatory actions required at this time.

Edarbyclor
(Azilsartan kamedoxomil and chlorthalidone)

 

NDA 202331

 

December 20, 2011
 

For the treatment of hypertension, to lower blood pressure: 
  - in patients not adequately controlled with monotherapy
  - as initial therapy in patients likely to need multiple drugs to help achieve blood pressure goals. 

Adverse event reports of decreased blood sodium/hyponatremia and angioedema were identified. 

FDA is continuing to evaluate decreased blood sodium/hyponatremia and angioedema to determine if regulatory action is required.

Gemcitabine HCl injection, USP
 

NDA 200795
 

August 4, 2011 

For the treatment of patients with:

Ovarian Cancer:
In combination with carboplatin of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

Breast Cancer:
First-line treatment in combination with paclitaxel of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

Non-Small Cell Lung Cancer:
First-line treatment in combination with cisplatin of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.

Pancreatic Cancer:
First-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. 

No new safety concerns were identified. 

No regulatory actions required at this time.