New Drug Application News and Research

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

Biovail Corporation has announced that the Food and Drug Administration (FDA) has accepted for review (effective date June 13, 2004) Biovail's submission of a New Drug Application (NDA) for a novel dosage format of citalopram for the treatment of depression.

14 Jun 2004

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

Solvay Pharmaceuticals unveiled this week results from a six-month study of both male and female patients and from a subgroup analysis of males with Irritable Bowel Syndrome with Diarrhea predominance (IBS-D).

24 May 2004

IMPAX receives final FDA approval for generic version of Sinemet CR

IMPAX Laboratories, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Carbidopa/Levodopa Extended Release Tablets, its generic version of Sinemet(R) CR tablets.

17 May 2004

FDA approval of topical anti-inflammatory cream

Atrix Laboratories, Inc. has announced the company received approval from the U.S. Food and Drug Administration (FDA) to market fluticasone propionate cream.

15 May 2004

FDA knocks back King Pharmaceuticals self-injectible epilepsy product

King Pharmaceuticals, Inc. has reported the receipt by its Meridian Technologies subsidiary of a letter from the U.S. Food and Drug Administration

13 May 2004

FDA approval for Cladribine to treat active Hairy Cell Leukemia

American Pharmaceutical Partners, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Cladribine Injection.

27 Apr 2004

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

Atrix Laboratories, Inc. announced today the company received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for fluticasone propionate cream, 0.05%.

27 Apr 2004

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

OSI Pharmaceuticals, Inc., Genentech, Inc., and Roche today announced that a Phase III study of Tarceva™ (erlotinib HCl), an investigational HER1/EGFR-inhibitor agent in previously treated patients with non-small cell lung cancer (NSCLC), met its primary endpoint of improving overall survival, with patients receiving Tarceva™ living longer than those in the placebo arm of the study.

26 Apr 2004

Schering-Plough submits Japanese application for hepatitis C drug

Schering-Plough Corporation has announced that Schering-Plough K.K., the company's subsidiary in Japan, has submitted a New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for PEG-INTRON(R) (peginterferon alfa-2b) Powder for Injection for use in combination with REBETOL(R) (ribavirin) Capsules for the treatment of chronic hepatitis C.

22 Apr 2004

FDA approval for skin cancer cream

3M has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) in response to its supplemental new drug application on Aldara (imiquimod) Cream, 5% for the treatment of superficial basal cell carcinoma (sBCC), a common form of non-melanoma skin cancer.

14 Apr 2004

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

Merck/Schering-Plough Pharmaceuticals today announced the regulatory approval of INEGYTM (ezetimibe/simvastatin) in Germany for the treatment of elevated cholesterol (hypercholesterolemia). INEGY is the first product to reduce low-density lipoprotein cholesterol (LDL-C or ‘bad’ cholesterol), along with diet and exercise, through dual inhibition by inhibiting cholesterol production in the liver and absorption in the intestine. The approval of INEGY in Germany represents the first approval in Europe for ezetimibe/simvastatin tablets and the first step in seeking marketing approval throughout the European Union (EU) under the EU’s mutual recognition procedure.

4 Apr 2004

Genencor Sells Its Therapeutic Vaccine Program to Innogenetics

Genencor International, Inc. today announced that it has agreed to sell its therapeutic vaccine program to Belgian biotechnology company Innogenetics N.V. Innogenetics will develop and commercialize current product candidates in Genencor’s vaccine product portfolio as well as future products based on intellectual property and technology held by Genencor.

30 Mar 2004

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

SuperGen Inc. announced today that the Food and Drug Administration (FDA) has officially accepted the Orathecin™ (rubitecan) capsules’ New Drug Application (NDA) for filing. Orathecin, an investigational anticancer compound, is an oral chemotherapy agent that has been investigated as a treatment for pancreatic cancer patients who have failed at least one prior chemotherapy.

26 Mar 2004

New drug to treat urinary tract infections, a step closer

Depomed, Inc. today announced top line results from the Phase III clinical trial of its Ciprofloxacin GR, an extended release formulation of ciprofloxacin HCl, which is used to treat urinary tract infections. The data confirmed Phase II results, demonstrating that Depomed's once-daily Ciprofloxacin GR eliminated the organisms responsible for urinary tract infections as effectively as twice-daily CIPRO(R), but with fewer gastrointestinal side effects, specifically fewer incidences of nausea and diarrhea.

22 Mar 2004