Handa Pharmaceuticals' 505(b)(2) new drug application for the smoking cessation aid HND-032 has completed experimental data on nitrosamine impurities and has recently submitted a complete response letter (CRL) supplement to the U.S. FDA. The outcome is expected as early as the fourth quarter of this year or early next year at the latest. Meanwhile, the company's U.S. antitrust case has reached a settlement with three major insurance company plaintiffs, with the settlement costs significantly lower than initially estimated, which is expected to facilitate settlements with other insurers.
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