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New Approvals Of FDA

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


On November 5, 2009, the U.S. Food and Drug Administration granted approval to romidepsin for injection (ISTODAX, Gloucester Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

The efficacy and safety of romidepsin were evaluated in two single-arm, multicenter, open label trials.  Efficacy was assessed in 167 patients with CTCL treated in the United States, Europe, and Australia.  Study 1 included 96 patients with CTCL who had received at least 1 prior systemic therapy. Study 2 included 71 patients with CTCL who received a median of 2 prior systemic therapies.  In both trials, patients could be treated until disease progression.  Overall response was evaluated according to a composite endpoint that included assessments of skin involvement, lymph node and visceral involvement, and Sézary cells.

The primary efficacy endpoint for both trials was the overall response rate (ORR) based on the investigator assessments, and defined as the proportion of patients with confirmed complete response (CR) or partial response (PR).  The ORRs in these two trials were similar (34 and 35% in Study 1 and Study 2, respectively) and CR rates were the same (6%).  The median response duration was 15 months in Study 1 and 11 months in Study 2. 

Safety data was available and evaluated in 185 patients with CTCL.  The most common adverse reactions in Study 1 were nausea, fatigue, infections, vomiting and anorexia.  The most common adverse reactions in Study 2 were nausea, fatigue, anemia, thrombocytopenia, ECG T-wave changes, neutropenia and lymphopenia.  Serious adverse reactions reported in > 2% of the patients in Study 1 were infection, sepsis, and pyrexia.  Serious adverse reactions reported in > 2% of the patients in Study 2 were infection, supraventricular arrhythmia, neutropenia, fatigue, edema, central line infection, ventricular arrhythmia, nausea, pyrexia, leukopenia, and thrombocytopenia.

The recommended dose and schedule of romidepsin is 14 mg/m2 intravenously over 4 hours on days 1, 8 and 15 of a 28-day cycle. 

Please refer to the full prescribing information at: Istodax



HIV/AIDS Update – Tentative Approval of Lamivudine and Tenofovir DF Fixed Dose Combination Tablets, 300mg/300mg

On November 5, 2009, using expedited review procedures developed to support the President’s Emergency Program For AIDS Relief (PEPFAR), the Food and Drug Administration (FDA), granted tentative approval for lamivudine and tenofovir disoproxil fumarate fixed dose combination tablets, 300mg/300mg.

The fixed dose combination product, indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection, is manufactured by Hetero Drugs Limited of Hyberdad, India.

FDA’s tentative approval of this product means that while FDA cannot fully approve the product for sale in the United States because of existing patent protections, it has been shown to meet all of FDA’s safety, efficacy and manufacturing quality standards. Tentative approval qualifies the product for purchase using PEPFAR funds.

Fixed dose combination products like this one can help ease pill burden and simplify therapy, and may help increase adherence to therapeutic regimens, potentially reducing development of resistance to the separate drugs. Fixed dose combination products can help also help reduce costs associated with treatment for HIV infection.

Lamivudine and tenofovir df are Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


November 13, 2009 - Posted by | 1

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