• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Postmarket Drug Safety Evaluation Summaries Completed from April 2013 through June 2013

 

 

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

Brilinta (Ticagrelor)

 

NDA 022433

 

July 20, 2011
 

To reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction).

Adverse event reports of neutropenia, thrombocytopenia, pancytopenia, and clinical gout were identified.

FDA is continuing to evaluate neutropenia, thrombocytopenia, pancytopenia, and clinical gout to determine if regulatory action is required.

Cleviprex (Clevidipine butyrate)

 

NDA 022156

 

August 1, 2008 

For the reduction of blood pressure when oral therapy is not feasible or not desirable.

No new safety concerns were identified.

No regulatory actions required at this time.

Daliresp (Roflumilast)

 

NDA 022522

 

February 28, 2011 

As a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

No new safety concerns were identified.

No regulatory actions required at this time.

Dificid (Fidaxomicin)

 

NDA 201699

 

May 27, 2011 

For the treatment of Clostridium difficile-associated diarrhea in adults (≥18 years of age).

No new safety concerns were identified.

No regulatory actions required at this time.

Horizant (Gabapentin encarbil)

 

NDA 022399

 

April 6, 2011

For the treatment of moderate to severe primary Restless Leg Syndrome (RLS) in adults.


For the management of postherpetic neuralgia in adults. 

Adverse event reports of hallucinations, abnormal dreams, and hyperuricemia were identified.FDA is continuing to evaluate hallucinations, abnormal dreams, and hyperuricemia to determine if regulatory action is required.
Incivek (Telaprevir)

 

NDA 201917

 

May 23, 2011 

For the treatment of genotype 1 chronic hepatitis C in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.No new safety concerns were identified.

No regulatory actions required at this time.

TachoSil (Absorbable Fibrin Sealant Patch)

 

BLA 125351

 

April 5, 2010 

Adjunct to hemostatsis in surgery where standard techniques are impractical or insufficient.No new safety concerns were identified.

No regulatory actions required at this time.

Tradjenta (Linagliptin)

 

NDA 201280

 

May 2, 2011 

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

 

Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
 

Adverse event reports of pancreatitis, hypersensitivity reaction, and medication errors involving excessive dosing were identified.The Indications and Usage and Warning and Precautions sections of the labeling for Tradjenta were updated in June 2013, to include information about reports of pancreatitis, including fatal pancreatitis.

 

FDA is continuing to evaluate hypersensitivity reactions and medication errors involving excessive dosing to determine if regulatory action is required. 

Vibativ (Telavancin)

 

NDA 022110

 

September 11, 2009
 

For the treatment of adult patients with complicated skin and skin structure infections caused by susceptible isolates of Gram-positive bacteria.

 

For the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Staphylococcus aureus. Vibativ should be reserved for use when alternative treatments are not suitable.

Adverse event reports of anaphylaxis and incorrect product reconstitution were identified.The Warnings and Precautions section of the labeling for Vibativ was updated in June 2013, to include information about anaphylaxis.


FDA is continuing to evaluate incorrect product reconstitution to determine if regulatory action is required.
 

Victrelis (Boceprevir)

 

NDA 202258

 

May 13, 2011 

For the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, and relapsers.

No new safety concerns were identified.No regulatory action required at this time.

 

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

Androgel
(Testosterone)

 

NDA 022309

 

April 29, 2011
 

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). 

No new safety concerns were identified.

No regulatory actions required at this time.

Argatroban injection in sodium chloride

 

NDA 022485

 

May 9, 2011
 

For the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia.

 

As an anticoagulant in adult patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention. 

No new safety concerns were identified.

No regulatory actions required at this time.

Complera
(Emtricitabine, rilpivirine, tenofovir disoproxil)

 

NDA 202123

 

August 10, 2011 

For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adults.

No new safety concerns were identified.
 

No regulatory actions required at this time.

Docetaxel injection, USP

 

NDA 201195

 

June 8, 2011

 

and

 

Docetaxel injection, USP

 

NDA 201525

 

June 29, 2011
 

For the treatment of patients with:

Breast Cancer:
For locally advanced or metastatic breast cancer after failure of prior chemotherapy.
In combination with doxorubicin and cyclophosphamide for the adjuvant treatment of operable node-positive breast cancer.

Non-Small Cell Lung Cancer:
For locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
In combination with cisplatin for unresectable, locally advanced or metastatic non-small cell lung cancer.

Prostate Cancer:
In combination with prednisone for androgen independent (hormone refractory) metastatic prostate cancer.

Gastric Adenocarcinoma:
In combination with cisplatin and fluorouracil for advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction.

Head and Neck Cancer:
In combination with cisplatin and fluorouracil for the induction treatment of locally advanced squamous cell carcinoma. 

No new safety concerns were identified.
 

No regulatory actions required at this time.

Fluoxetine hydrochloride

 

NDA 202133

 

October 6, 2011
 

For the treatment of:
Major Depressive Disorder (MDD) in adults and in pediatric patients (8-18 years);
Obsessive Compulsive Disorder (OCD) in adults and in pediatric patients (7-17 years);
Bulimia Nervosa in adults;
Panic Disorder, with or without agoraphobia in adults. 

No new safety concerns were identified.

 

No regulatory actions required at this time.

Fortesta
(Testosterone)

 

NDA 021463

 

December 29, 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). 

No new safety concerns were identified.

No regulatory actions required at this time.

Heparin sodium injection, USP

 

NDA 201370

 

July 21, 2011
 

Prophylaxis and treatment of venous thromboembolism.

 

Prophylaxis and treatment of the thromboembolic complications associated with atrial fibrillation.

 

Treatment of acute and chronic consumption coagulopathies.

 

Prevention of clotting in arterial and cardiac surgery.

 

Prophylaxis and treatment of peripheral arterial embolism.

 

Anticoagulant use in transfusion, extracorporeal circulation, and dialysis procedures. 

Adverse event reports of heparin-induced hyperkalemia were identified.

FDA is continuing to evaluate heparin-induced hyperkalemia to determine if regulatory action is required.

Kapvay/Jenloga
(Clonidine hydrochloride)

 

NDA 022331

 

February 28, 2010
 

Kapvay is indicated for the treatment of ADHD in children and adolescents as monotherapy and adjunctive therapy to stimulant medications.

 

Jenloga is indicated for the treatment of hypertension. 

No new safety concerns were identified.

No regulatory actions required at this time.

Morphine sulfate oral solution, USP

 

NDA 201517

 

June 23, 2011 

For the management of moderate to severe acute and chronic pain in opioid-tolerant patients.

No new safety concerns were identified.

No regulatory actions required at this time.

Nucynta ER
(Tapentadol extended-release)

 

NDA 200533

 

August 25, 2011
 

For the management of moderate to severe chronic pain in adults and neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.Adverse event reports of hypertension, extrapyramidal syndrome, and renal insufficiency were identified.FDA is continuing to evaluated hypertension, extrapyramidal syndrome, and renal insufficiency to determine if regulatory action is required.
Rezira
(Hydrocodone bitartrate and pseudoephedrine hydrochloride)

 

NDA 022442

 

June 8, 2011 

For the relief of cough and nasal congestion associated with the common cold. Not for use by pediatric patients under 18 years.

No new safety concerns were identified.

No regulatory actions required at this time.

Staxyn
(Vardenafil hydrochloride)

 

NDA 200179

 

June 17, 2010 

For the treatment of erectile dysfunction.

No new safety concerns were identified.

No regulatory actions required at this time.

Veltin
(Clindamycin phosphate and tretinoin)

NDA 050803

July 16, 2010 

For the topical treatment of acne vulgaris in patients 12 years and older.

No new safety concerns were identified.

No regulatory actions required at this time.

Zutripro
(Hydrocodone bitartrate; chlorpheniramine maleate; pseudoephedrine hydrochloride)

 

NDA 022439

 

June 8, 2011 

For the relief of cough and nasal congestion associated with common cold.


For the relief of symptoms including nasal congestion associated with upper respiratory allergies. Not for pediatric patients under 18 years. 

No new safety concerns were identified.

No regulatory actions required at this time.