U.S. Revokes Approval For Ranbaxy Laboratories Copies Of AstraZeneca PLC, Roche Drugs

Published: Nov 07, 2014

U.S. Revokes Approval For Ranbaxy Laboratories’ Copies Of AstraZeneca PLC, Roche Drugs

November 6, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration has revoked approval for Ranbaxy Laboratories’ plans to develop a copy of AstraZeneca ’s drug, Nexium, as well as its copy of Roche ’s antiviral drug, Valcyte. The news came today after its plants across India were banned due to quality control issues, according to Reuters.

The U.S. government has banned all of Ranbaxy’s India-based plants under scrutiny of the country’s $15 billion pharmaceutical industry. India is one of the largest suppliers of generic drugs to the U.S.

Ranbaxy was the first company to receive tentative approvals for more affordable copies of Valcyte and Nexium back in 2008, according to the India Times. Since then, the company has been faced with delays as a result of quality control issues at its manufacturing plants.

The active ingredient in Nexium is esomeprazole magnesium, which helps selectively inhibit the activity of an enzyme responsible for pumping acid. Nexium capsules have been globally approved and sold in more than 120 countries around the world.

Valcyte, which is also known as valganciclovir hydrochloride, is typically prescribed to those who are living with AIDS for the treatment of cytomegalovirus retinitis, which affects the eye. The drug works by inhibiting the ability of the virus to replicate within the body and become stronger. When the immune system is weakened, it may be challenging for the body to fight off a virus such as the cytomegalovirus.

Fenofibrate Approval
Although Ranbaxy has been under fire as of late, its subsidiary Ranbaxy Pharmaceuticals Inc. announced on Nov. 5 that the FDA had granted approval to manufacture and market Fenofibrate, which is designed to treat primary hypercholesterolemia and mixed dyslipidemia. It is also being indicated for the treatment of severe hypertriglycemia in patients.

“We are pleased to receive approval for these two strengths of Fenofibrate capsules, which represents a welcome addition to our generic portfolio of products and offer an alternative in strengths and dosage forms for this molecule to patients and healthcare professionals,” said Dan Schober, vice president of Trade Sales at Ranbaxy. “The product will be manufactured at Ohm Laboratories in our U.S. facility located in New Brunswick, New Jersey and launched immediately thereafter.”

Ranbaxy Pharmaceuticals is headquartered in Jacksonville, Fla. It is engaged in the sale and distribution of generic and branded prescription products within the U.S.

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