Drugs

Postmarket Drug Safety Evaluation Summaries Completed from January 2013 through March 2013

 

 

New Molecular Entities and Biological Products 
 

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

Actemra
(Tocilizumab) 
 

BLA 125276 
 

January 8, 2010

For the treatment of rheumatoid arthritis (RA) 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.

For the treatment of systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older with active systemic juvenile idiopathic arthritis.

No unlabeled or unexpected serious adverse events were identified.

No regulatory action required at this time.

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
 

BLA 125296
 

March 16, 2011

Adenovirus type 4 and type 7 Vaccine is indicated for active immunization for the prevention of febrile acute respiratory disease caused by adenovirus type 4 and type 7, and approved for use in the United States military population 17 through 50 years of age.

No new safety concerns were identified.

No regulatory actions required at this time.

Berinert
(C1 Esterase Inhibitor [Human])
 

BLA 125287
 

October 9, 2009

Treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients.

No new safety concerns were identified.

No regulatory actions required at this time.

Edarbi
(Azilsartan kamedoxomil)
 

NDA 200796
 

February 25, 2011

An angiotensin II receptor blocker (ARB) for the treatment of hypertension to lower blood pressure.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Adverse event reports of angioedema and anaphylaxis were identified.

FDA is continuing to evaluate the reports of angioedema and anaphylaxis to determine if regulatory action is required.

Treanda
(Bendamustine hydrochloride)
 

NDA 022249
 

March 20, 2008

For the treatment of patients with chronic lymphocytic leukemia (CLL).

For the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Adverse event reports of pneumocystis pneumonia were identified.

FDA is continuing to evaluate the reports of pneumocystis pneumonia 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

Children’s Allegra Allergy
Children’s Allegra Hives
(Fexofenadine hydrochloride)
 

NDA 201373
 

January 24, 2011

For temporary relief of symptoms due to hay fever or other upper respiratory allergies.
For the reduction of hives and the relief of itching due to hives (urticaria).

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Conzip
(Tramadol hydrochloride) extended-release
 

NDA 022370
 

May 7, 2010

For the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Docetaxel injection, USP
 

NDA 022234
 

March 8, 2011

For the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.

In combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable node-positive breast cancer.

For the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.

In combination with cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.

In combination with prednisone for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Duexis
(Ibuprofen and famotidine)
 

NDA 022519
 

April 23, 2011

For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and decrease the risk of developing upper gastrointestinal ulcers (defined in clinical trials as gastric and/or duodenal) in patients who are taking ibuprofen for those indications.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Flo-Pred
(Prednisolone acetate)
 

NDA 022067
 

January 17, 2008

For the treatment of the following diseases or conditions:
allergic conditions, dermatologic diseases, endocrine diseases, hematologic diseases, neoplastic conditions, nervous system conditions, ophthalmic conditions, conditions related to organ transplantation, pulmonary diseases, renal conditions, rheumatologic conditions, specific infections diseases.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Gralise
(Gabapentin)
 

NDA 022544
 

January 28, 2011

For the management of postherpetic neuralgia.

Adverse event reports of anaphylactic reactions were identified.

FDA is continuing to evaluate the reports of anaphylactic reactions to determine if regulatory ation is required.

Lotemax ophthalmic ointment 0.5%
(Loteprednol etabonate)
 

NDA 200738
 

April 15, 2011

For the treatment of post-operative inflammation and pain following ocular surgery.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Ofirmev injection
(Acetaminophen)
 

NDA 022450
 

November 2, 2010

For the management of mild to moderate pain.

For the management of mild to moderate pain with adjunctive opioid analgesics.

For the reduction of fever.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Suboxone
(Buprenorphine hydrochloride and naloxone hydrochloride) sublingual film
 

NDA 022410
 

August 30, 2010

For maintenance treatment of opioid dependence.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

 

Page Last Updated: 12/10/2014
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