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FDA approves Amneal addiction drug
Amneal Pharmaceuticals Llc. has won federal approval for a generic version of Suboxone, a popular medicine used for the treatment of addiction to prescription drugs.
The generic tablets, called buprenorphibe hydrochloride and naloxone HCI dehydrate, will be made at Amneal’s South Yaphank factory. The federal Food and Drug Administration recently turned down a challenge from Suboxone maker Reckitt Benckiser Healthcare Ltd.
Sales of Suboxone topped $1.5 billion in the United States last year, according to the IMS Health news services.
“The FDA determined that Reckitt’s petition did not raise valid scientific or regulatory issues associated with the product, which Amneal contended in its comments on the petition,” said Chintu Patel, chief executive of New Jersey-based Amneal. “Physicians should have no concerns in writing prescriptions for the generic tablet form of" Suboxone.
Amneal is in the midst of quadrupling the size of its factory in South Yaphank, which would add 400 jobs there over five years.