FDA approvals

Pioglitazone approved by FDA for abbreviated new drug application

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.

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.