Generic Drug for Stroke Prevention Granted FDA Approval

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.