FDA Grants Approval To Rizatriptan Benzoate ODT For Acute Migraine Treatment

Migraine Blog Rizatriptan ODT

Rizatriptan Benzoate ODT approved by FDA and launched in the market.  Image is not of said drug (1)

Pharmaceutical company Breckenridge’s drug Rizatriptan Benzoate has been given the green flag for immediate launch by the U.S Food and Drug Administration. The drug comes in the form of orally disintegrating tablet (ODT). It is available commercially in packs of potency/dosage 5 mg and 10 mg.

Breckenridge’s drug Rizatriptan Benzoate ODT is manufactured and supplied by Natco Pharma Limited. Just like Merck & Co. Inc’s Maxalt MLT, Rizatriptan Benzoate ODT is a prescription drug used in the management and treatment of acute migraine.

The FDA granted final ‘go ahead’ for the Abbreviated New Drug Application (ANDA) for Rizatriptan Benzoate ODT some nine months prior to expiration of the pediatric-exclusivity period for the challenged Orange Book patent (April 1, 2014).

‘Breckenridge’s patent challenge regarding Rizatriptan Benzoate Orally Disintegrating Tablets is a continuing part of its larger aggressive Paragraph IV strategy commenced a few years ago. Since the beginning of 2011, Breckenridge has filed twelve (12) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.’ (2)

SOURCES:

  1. Image Credit: FreeDigitalPhotos.net; Yellow Tablet; Image by rakratchada torsap; Web July 2013; http://www.freedigitalphotos.net/images/agree-terms.php?id=10096441
  2. Breckenridge Pharmaceutical, Inc. Announces Approval of Rizatriptan Benzoate ODT (Orally Disintegrating Tablets): BioSpace.com; Web July 2013;  http://www.biospace.com/news_story.aspx?StoryID=301892&full=1

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