FDA Officials Approve Generic Stroke Prevention Drug

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

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

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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).

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

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

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

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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.

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References

  1. 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.
  2. Boehringer Ingelheim. Aggrenox. BI website. https://www.boehringer-ingelheim.com/products/aggrenox. Accessed March 27, 2019.
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