Generic Drug for Stroke Prevention Granted FDA Approval

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Lannett officials said that the company received approval of its Abbreviated New Drug Application (ANDA) for Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, a generic version of Aggrenox® Capsules, 25 mg/200 mg (Boehringer Ingelheim Pharmaceuticals).

Lannett Company’s therapeutic equivalent to Aggrenox (dipyridamole) Capsules has been approved by the FDA.1

In Wednesday’s announcement, Lannett officials said that the company received approval of its Abbreviated New Drug Application (ANDA) for Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, a generic version of Aggrenox® Capsules, 25 mg/200 mg (Boehringer Ingelheim Pharmaceuticals).1

Aggrenox is indicated for secondary prevention of stroke and transient ischaemic attacks (TIA).2

According to Tim Crew, chief executive officer of Lannett, the company’s generic dipyridamole capsules are expected to launch in the near term.1

"The commercial opportunity for our Aspirin and Extended-Release Dipyridamole Capsules product, which was developed internally, is meaningful," said Crew, in a prepared statement.1

Total US sales of Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, was approximately $174.6 million for the 12 months ending January 2019, according to IQVIA, although actual generic market values are expected to be lower.1

References

  • Lannett Receives FDA Approval For Aspirin And Extended-Release Dipyridamole Capsules, 25 mg/200 mg [news release]. Philadelphia, PA; March 27, 2019: Lannett website. http://lannett.investorroom.com/2019-03-27-Lannett-Receives-FDA-Approval-For-Aspirin-And-Extended-Release-Dipyridamole-Capsules-25-mg-200-mg. Accessed March 27, 2019.
  • Boehringer Ingelheim. Aggrenox. BI website. https://www.boehringer-ingelheim.com/products/aggrenox. Accessed March 27, 2019.

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