FDA grants final approval to Breckenridge’s Pioglitazone Hydrochloride ANDA

Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Pioglitazone Hydrochloride Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by Synthon Pharmaceuticals, Inc., and will be available in 15 mg, 30 mg, and 45 mg strengths. 

Breckenridge is launching its 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® a once-daily oral prescription medication that, with diet and exercise, has been shown to be effective for the treatment of type 2 diabetes, and is marketed by Takeda Pharmaceutical. According to industry data, Actos® had approximately $3.7 billion in brand sales for the twelve months ending August 2012, prior to generic competition. 

Source:

Breckenridge Pharmaceutical, Inc.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Ultra-processed foods dominate children's diets from toddlerhood to middle childhood