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U.S. Department of Health and Human Services

Drugs

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Postmarket Drug and Biologic Safety Evaluation Summaries Completed from July 2012 through December 2012

 


New Molecular Entities and Biological Products
 

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

Ampyra
(Dalfampridine)            

NDA 022250

January 22, 2010    

A treatment to improve walking in patients with multiple sclerosis (MS). Adverse event reports of seizures and medication errors were identified.FDA is continuing to evaluate the reports of seizures to determine if the current labeling, which includes seizures in the Warnings and Precautions section, is adequate.

FDA is continuing to evaluate the reports of medication errors to determine if regulatory action is required. 

Eovist
(Gadoxetate disodium)                  

NDA 022090

July 3, 2008 

For intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease. No unlabeled or unexpected serious adverse events were identified. No regulatory action required at this time. 
Firmagon
(Degarelix)

NDA 022201

December 24, 2008 

For the treatment of patients with advanced prostate cancer. Adverse event reports of anaphylaxis and cardiovascular disease risk were identified. The Warnings and Precautions section of the labeling for Firmagon was updated in March 2013 to include additional information about hypersensitivity reactions including anaphylaxis.

FDA is continuing to evaluate the reports of cardiovascular disease risk to determine if regulatory action is required. 

Gilenya
(Fingolimod)

NDA 022527

September 21, 2010 

For the treatment of patients with relapsing multiple sclerosis (MS) to reduce the frequency of relapses and to delay the progression of disability. Adverse event reports of Posterior Reversible Encephalopathy Syndrome (PRES), CNS Lesions/MS Relapse/Atypical MS, seizures, neutropenia, herpes zoster infections, retinal vein occlusion, and medication errors were identified. FDA is continuing to evaluate the reports of  PRES, CNS Lesions/MS Relapse/Atypical MS, seizures, neutropenia, herpes zoster infections, retinal vein occlusion, and medication errors to determine if regulatory action is required. 

Lastacaft
(Alcaftadine ophthalmic solution) 0.25% 

NDA 022134

July 28, 2010 

For the prevention of itching associated with allergic conjunctivitis. No unlabeled or unexpected serious adverse events were identified.  No regulatory action required at this time.

Natroba
(Spinosad)

NDA 022408

January 18, 2011 

For the topical treatment of head lice infestation in patients 4 years of age and older. No unlabeled or unexpected serious adverse events were identified. No regulatory action required at this time. 

Pradaxa
(Dabigatran etexilate mesylate)

NDA 022512

October 19, 2010

To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. 

Adverse event reports of bleeding events, with gastrointestinal, cerebral, and rectal hemorrhage being the most frequently reported, were identified.

Adverse event reports of medication errors were identified.

FDA Drug Safety Communication 

The Warnings and Precautions section of the labeling for Pradaxa was updated in November 2012 to include additional information about the risk of bleeding.

FDA is continuing to evaluate the reports of medication errors to determine if regulatory action is required. 

Samsca
(Tolvaptan)

NDA 022275

May 19, 2009 

For the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Adverse event reports of Osmotic Demyelination Syndrome (ODS) were identified. FDA is continuing to evaluate the reports of ODS to determine if the current labeling, which includes ODS in the Boxed Warning section, is adequate. 
Stelara
(Ustekinumab)

BLA 125261

September 25, 2009 

For the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Adverse event reports of cardiovascular events were identified. FDA is continuing to evaluate the reports of cardiovascular events to determine if regulatory action is required. 
Teflaro
(Ceftaroline fosamil)

NDA 200327

October 29, 2010 

For the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Community-Acquired Bacterial Pneumonia (CABP) caused by susceptible isolates of Gram-positive and Gram-negative microorganisms. No unlabeled or unexpected serious adverse events were identified. No regulatory action required at this time. 

Viibryd)
(Vilazodone hydrochloride)

NDA 022567

January 21, 2011

For the treatment of major depressive disorder (MDD). No unlabeled or unexpected serious adverse events were identified. No regulatory action required at this time. 

Xgeva
(Denosumab)

BLA 125320

June 1, 2010 

For the prevention of skeletal-related events in patients with bone metastases from solid tumors. Adverse event reports of bone pain, and medication errors were identified. FDA is continuing to evaluate the reports of bone pain and medication errors 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
Findings
Actions Taken and
Ongoing Surveillance
Activities

Advil Congestion Relief             
(Ibuprofen 200 mg /phenylephrine hydrochloride 10 mg)

NDA 022565  

May 27, 2010      

For the temporary relief of the following symptoms associated with cold and flu: headache, fever, sinus pressure, nasal congestion, minor aches and pains; reduces swelling of the nasal passages; restores freer breathing through nose.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.

Aricept 23 mg
(Donepezil hydrochloride)       

NDA 022568

July 23, 2010 

For the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Axiron
(Testosterone)

NDA 022504

November 23. 2010

For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired); Hypogonadotropic hypogonadism (congenital or acquired) 
Adverse event reports of thromboembolic events were identified. FDA is continuing to evaluate the reports of thromboembolic events to determine if regulatory action is required. 
Beyaz
(Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium)

NDA 022532

September 24, 2010 

For use by women to prevent pregnancy.

For the treatment of symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception.

For the treatment of moderate acne vulgaris in women at least 14 years of age only if the patient desires an oral contraceptive for birth control.

In women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. 

No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time. 
Cefepime for injection in Galaxy container, for intravenous use
(Cefepime hydrochloride)

NDA 050817

August 5, 2008 

For the treatment of moderate to severe pneumonia, uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections, complicated intra-abdominal infections (used in combination with metronidazole), and empiric therapy for febrile neutropenic patients in infections caused by susceptible strains of the designated microorganisms. No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time. 
Dulera
(Mometasone furoate/formoterol fumarate) inhalation aerosol

NDA 022518

June 22, 2010 

For the treatment of asthma in patients 12 years of age and older. No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.  
Feraheme
(Ferumoxytol)

NDA 022180

June 30, 2009 

For the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). No unlabeled or unexpected serious adverse events were identified.  No regulatory actions required at this time.   
Fusilev injection
(Levoleucovorin calcium)

NDA 020140

March 7, 2008 

A folate analog:
For rescue after high-dose methotrexate therapy in osteosarcoma;
To diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists;
For use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. 
No unlabeled or unexpected serious adverse events were identified.   No regulatory actions required at this time.  
Kombiglyze XR
(Saxagliptin and metformin hydrochloride) extended-release

NDA 200678

November 5, 2010 

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. No unlabeled or unexpected serious adverse events were identified.  No regulatory actions required at this time. 
Lo Loestrin Fe
(Norethindrone acetate and ethinyl estradiol, ethinyl estradiol, ferrous fumerate)

NDA 022501

October 21, 2010 

For use by women to prevent pregnancy. No unlabeled or unexpected serious adverse events were identified.   No regulatory actions required at this time.  
Lumigan
(Bimatoprost) ophthalmic solution 0.01%

NDA 022184

August 31, 2010

For the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.
Mirapex ER
(Pramipexole dihydrochloride) extended-release

NDA 022421

February 19, 2010

For the treatment of the signs and symptoms of idiopathic Parkinson’s disease.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Moxeza
(Moxifloxacin hydrochloride) ophthalmic solution

NDA 022428

November 19, 2010 

For the treatment of bacterial conjunctivitis caused by susceptible strains of organisms.No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time. 
Nexterone IV
(Amiodarone hydrochloride)

NDA 022325

December 24, 2008

For the treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.
Generess Fe
(Norethindrone and ethinyl estradiol and ferrous fumarate) chewable tablets

NDA 022573

December 22, 2010

For use by women to prevent pregnancy.No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.
Oxycodone hydrochloride 5 mg capsule

NDA 200534

October 20, 2010

For the management of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Oxycodone hydrochloride 20 mg/mL liquid

NDA 200535

October 20, 2010

For the management of moderate to severe acute and chronic pain in opioid-tolerant patients.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Protonix
(Pantoprazole sodium)

NDA 022020

November 14, 2007

For the short-term treatment of erosive esophagitis associated with Gastroesophageal Reflux Disease (GERD).

For the maintenance of healing of erosive esophagitis.

For the treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome.

No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Safyral
(Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium)

NDA 022574

December 16, 2010

For use by women to prevent pregnancy.
In women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.
No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Tekamlo
(Aliskiren hemifumarate/amlodipine besylate)

NDA 022545

August 26, 2010

For the treatment of hypertension, to lower blood pressure:
As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals;
In patients not adequately controlled with monotherapy;
As a substitute for its titrated components.
No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Vimpat
(Lacosamide) solution for injection

NDA 022254

October 28, 2008 

Injectable lacosamide is indicated adjunctively as short term replacement when oral administration is not feasible in patients with partial-onset seizures ≥ 17 years of age. Adverse event reports of serious cardiac events (including atrioventricular blocks) were identified. FDA is continuing to evaluate the reports of serious cardiac events to determine if the current labeling, which includes cardiac rhythm and conduction abnormalities in the Warning and Precautions section, is adequate.