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Pioglitazone approved by FDA for abbreviated new drug application

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The FDA announced it has approved the abbreviated new drug application for pioglitazone, indicated for the treatment of type 2 diabetes in addition to diet and exercise.

According to a press release, the thiazolidinedione has been given full approval for the application currently manufactured and supplied by Synthon Pharmaceuticals, Inc. and Breckenridge Pharmaceutical, Inc. It will be available in 15-mg, 30-mg, and 45-mg doses.

According to the release, Breckenridge is launching the abbreviated new drug application (ANDA) prior to patent expiration pursuant to a settlement of Paragraph IV patent litigation with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, Inc., who granted Breckenridge and Synthon a license to applicable patents to sell and distribute its ANDA.

Pioglitazone hydrochloride is AB rated to Actos, according to the release.