New Drug Application News and Research

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Endo announces agreement With FDA for new trial design of oxymorphone extended-release tablets

Endo announces agreement With FDA for new trial design of oxymorphone extended-release tablets

New drug application for cilansetron, an investigational product for the treatment of irritable bowel syndrome

New drug application for cilansetron, an investigational product for the treatment of irritable bowel syndrome

New drug application for regulatory approval of exenatide for the treatment of type 2 diabetes

New drug application for regulatory approval of exenatide for the treatment of type 2 diabetes

Alcon updates filing status of RETAANE® new drug application

Alcon updates filing status of RETAANE® new drug application

Exelixis files new drug application for a proprietary novel anticancer compound

Exelixis files new drug application for a proprietary novel anticancer compound

FDA finds gepirone ER “not approvable” as a treatment for Major Depressive Disorder

FDA finds gepirone ER “not approvable” as a treatment for Major Depressive Disorder

Investigational drug Abraxane is active and well tolerated in women with metastatic breast cancer

Investigational drug Abraxane is active and well tolerated in women with metastatic breast cancer

New Drug Application for a novel dosage format of citalopram for the treatment of depression

New Drug Application for a novel dosage format of citalopram for the treatment of depression

Significant symptom relief reported in clinical trial patients with irritable bowel syndrome

Significant symptom relief reported in clinical trial patients with irritable bowel syndrome

IMPAX receives final FDA approval for generic version of Sinemet CR

IMPAX receives final FDA approval for generic version of Sinemet CR

FDA approval of topical anti-inflammatory cream

FDA approval of topical anti-inflammatory cream

FDA knocks back King Pharmaceuticals self-injectible epilepsy product

FDA knocks back King Pharmaceuticals self-injectible epilepsy product

FDA approval for Cladribine to treat active Hairy Cell Leukemia

FDA approval for Cladribine to treat active Hairy Cell Leukemia

First generic cultivate(R) cream to receive tentative FDA approval

First generic cultivate(R) cream to receive tentative FDA approval

New cancer drug Tarceva - a breakthrough with significant survival benefit in patients with advanced lung cancer

New cancer drug Tarceva - a breakthrough with significant survival benefit in patients with advanced lung cancer

Schering-Plough submits Japanese application for hepatitis C drug

Schering-Plough submits Japanese application for hepatitis C drug

FDA approval for skin cancer cream

FDA approval for skin cancer cream

First Approval in Europe of Ezetimibe/Simvastatin for treatment of elevated cholesterol

First Approval in Europe of Ezetimibe/Simvastatin for treatment of elevated cholesterol

Genencor Sells Its Therapeutic Vaccine Program to Innogenetics

Genencor Sells Its Therapeutic Vaccine Program to Innogenetics

Oral chemotherapy agent Orathecin™ (rubitecan) capsules accepted by FDA for filing

Oral chemotherapy agent Orathecin™ (rubitecan) capsules accepted by FDA for filing