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What is FDA Posting?
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Why is FDA posting this summary information?
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What information is provided on this website?
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What information does FDA consider for these postmarket safety evaluations?
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How is the information analyzed?
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Postmarket Drug Safety Evaluation Summaries
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 October 2013 – December 2013 -
previous summaries
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This website provides summary information about ongoing and completed postmarket safety evaluations of adverse experience reports made to FDA for New Drug Applications (NDAs) and Biologics License Applications (BLAs) approved since September 27, 2007. The evaluations are done to determine if there are any new serious adverse events not previously identified during product development, known side effects reported in unusual number, or potential new safety concerns now that the products are being used in the general population. In accordance with Title IX, section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) which created a new section 505(r) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 355(r)), these postmarket evaluations are performed 18 months after approval of the drug or after its use by 10,000 individuals, whichever is later.
Postmarket Drug Safety Information for Patients and Providers website, which has links to a wide variety of drug safety information, including this web page.Â
Postmarket Drug Safety Information for Patients and Providers or Safety and Availability (Biologics).
Postmarket Drug and Biologic Safety Evaluation Summaries
(previous Postmarket Drug and Biologic Safety Evaluations)
New Molecular Entities and Biological Products
All Other ProductsÂ
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New Molecular Entities and Biological Products  Â
Product Name: Trade
(Active Ingredient)
NDA/BLA Number
Approval DateMajor Indication(s)Summary of Evaluation FindingActions Taken and Ongoing Surveillance Activities
Afinitor
(Everolimus)
NDA 022334
March 30, 2009
For the treatment of patients with:
Breast Cancer:
In postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.
Pancreatic Cancer:
In adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic. Afinitor is not indicated for the treatment of patients with functional carcinoid tumors.
Renal Cancer:
In adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.
In adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery.
In pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected.
Adverse event reports of liver failure, pulmonary hypertension, and Pneumocystis jiroveci pneumonia were identified.
Adverse event and literature reports of heart failure and left ventricular dysfunction were identified.
Medication error reports of wrong technique were identified.
FDA is continuing to evaluate liver failure, pulmonary hypertension, Pneumocystis jiroveci pneumonia, heart failure, left ventricular dysfunction, and medication error reports of wrong technique events to determine if regulatory actions are required.
Ella
(Ulipristal acetate)
NDA 022474
August 13, 2010
Emergency contraceptive for the prevention of pregnancy following unprotected intercourse of a known or suspected contraception failure.
Not intended for routine use as a contraceptive.
Adverse event reports of exposure during pregnancy and use beyond the recommended time frame of 5 days (120 hours) after unprotected intercourse were identified.
No regulatory action required at this time.
Ixempra
(Ixabepilone)
NDA 022065
October 16, 2007
For the treatment of patients with breast cancer:
In combination with capecitabine in patients with metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane.
As monotherapy in patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine.
No new safety concerns were identified.
No regulatory action required at this time.
Onfi
(Clobazam)
NDA 202067
October 21, 2011
For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Adverse event reports of urinary retention and hypothermia, some possibly associated with shock, were identified.
FDA is continuing to evaluate urinary retention and hypothermia events to determine if regulatory action is required.
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