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FDA Approves New Methadone Label

WILMINGTON, N.C., Feb. 13 /PRNewswire-FirstCall/ -- aaiPharma Inc. (NASDAQ:AAII) announced today that it has received approval of a new methadone label from the U.S. Food and Drug Administration for its parenterally administered methadone product (formerly branded as Dolophine(R) Injection).

"Methadone hydrochloride injection is an important product for patients in moderate to severe pain requiring intrathecal, intravenous, subcutaneous or intramuscular treatment," commented Dr. Philip S. Tabbiner, President and Chief Executive Officer of aaiPharma. "We are pleased with the collaborative effort with the FDA that led to the labeling we received and are ready to meet the patient need for this medically necessary pain management treatment."

aaiPharma offers physicians and patients one of the most comprehensive portfolios of pain products. Currently, the Company markets the Darvon(R) and Darvocet A500(TM) family of pain management products for the treatment of mild-to-moderate pain, and is developing a pipeline of line extensions to this brand franchise as well as novel products for the treatment of pain. These products, coupled with the recently acquired Oramorph(R) SR, Roxicodone(R), Roxanol(TM) and Duraclon(R) products, will provide physicians with treatment options across a broad spectrum of prescription pain relief.

About Methadone Hydrochloride Injection
This product is a parenterally administered methadone product indicated for the treatment of moderate to severe pain not responsive to non-narcotic analgesics, and for use in temporary treatment of opioid dependence in patients unable to take oral medication.

Methadone hydrochloride injection is contraindicated in patients with a known hypersensitivity to methadone or any situation in which opioids are contra-indicated, e.g., patients with respiratory depression, acute bronchial asthma or hypercarbia. Methdaone should be administered with particular caution to patients already at risk for development of prolonged QT interval (e.g., cardiac hypertrophy, concomitant diuretic use, hypokalemia, hypomagnesemia). Careful monitoring is recommended when using methadone in patients with a history of cardiac conduction abnormalities, those taking medications affecting cardiac conduction, and in other cases where history or physical exam suggest an increased risk of dysrhythmia. Methadone hydrochloride, a narcotic, is a Schedule II controlled substance under the Federal Controlled Substances Act.

Source: aaiPharma Inc.

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