Mylan Laboratories Inc. Announces FDA Acceptance of NDA for Nebivolol

Strategic Insights -

Mylan Laboratories Inc.'s subsidiary, Mylan Bertek Pharmaceuticals Inc., has made significant progress in the development of nebivolol, a treatment for hypertension. The company has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), which has accepted the submission for review. Clinical trials involving over 2,000 patients have demonstrated the efficacy and safety of nebivolol in lowering blood pressure in hypertensive patients. Mylan Laboratories Inc. is a leading pharmaceutical company with a diverse portfolio of generic and proprietary products.

Key Takeaways:

  • Mylan Bertek Pharmaceuticals Inc.'s New Drug Application (NDA) for nebivolol has been accepted for filing by the FDA.
  • The application is based on data from more than 2,000 patients enrolled in clinical trials, demonstrating the efficacy and safety of nebivolol.
  • Nebivolol is a highly beta-1 selective (cardioselective) blocker that increases nitric oxide levels, contributing to its effectiveness in lowering blood pressure.
  • In clinical trials, nebivolol was well-tolerated with an incidence of adverse events similar to that of placebo.
  • Mylan Bertek Pharmaceuticals Inc. filed its NDA with the FDA on April 28, 2004, and the FDA has provided an action date of February 28, 2005.
  • The company is progressing towards the approval and launch of nebivolol, a valuable treatment for hypertension.
  • Mylan Laboratories Inc. has a diverse portfolio of over 1,000 products, including generic and proprietary medications.
  • Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc., and Mylan Bertek Pharmaceuticals Inc.

Statistics:

  • The FDA has provided an action date of February 28, 2005, for the review of nebivolol's NDA.
  • Over 2,000 patients were enrolled in clinical trials to demonstrate the efficacy and safety of nebivolol.
  • In vitro studies have demonstrated that nebivolol is a highly beta-1 selective (cardioselective) blocker.
  • Clinical trials showed that nebivolol was well-tolerated, with an incidence of adverse events similar to that of placebo.

Sources:

  • Mylan Laboratories Inc.'s press release, April 29, 2004.
  • U.S. Securities and Exchange Commission (SEC) filings, including the Company's periodic reports filed with the SEC.