FDA approves Amneal’s generic Suboxone to treat opioid drug dependence

Published on February 25, 2013 at 6:48 AM · No Comments

"The FDA's decision to approve the first generic equivalents to Suboxone® sublingual tablets will ensure that millions of patients in the U.S. who need this product now have access to a high quality, low cost generic version," said Chirag Patel, President and Co-Chairman of Amneal. "Since the agency has issued its opinion on Reckitt Benckiser's September 2012 Citizen's Petition in favor of generic competition, Amneal's buprenorphine HCl and naloxone HCl tablets can offer consumers and physicians greater choice in opioid addiction treatment. We are also pleased that the FDA has referred this matter to the Federal Trade Commission to investigate and address Reckitt's anticompetitive business practices."

"We appreciate the FDA's thorough assessment of Reckitt's Citizen's Petition and applaud their recent decision to deny it in its entirety," said Chintu Patel, Amneal CEO and Co-Chairman. "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. Physicians should have no concerns in writing prescriptions for the generic tablet form of the product."

Manufactured in Amneal's fully FDA-compliant Brookhaven, NY facility, buprenorphine HCl and naloxone HCl tablets will be available through wholesalers and distributors as well as directly to the trade. The product received FDA approval under an approved Risk Evaluation and Mitigation Strategy (REMS), known as the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS program, and will be distributed in accordance with FDA and U.S. Drug Enforcement Administration (DEA) regulations governing the handling of CIII controlled substances. The generic tablets will be available to patients when the BTOD REMS program becomes operational in early March.

Source: Amneal Pharmaceuticals, LLC

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