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GoNitro FDA Approval History

FDA Approved: Yes (First approved June 8, 2016)
Brand name: GoNitro
Generic name: nitroglycerin
Dosage form: Sublingual Powder
Company: Espero Biopharma
Treatment for: Angina Pectoris Prophylaxis

GoNitro (nitroglycerin) is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

GoNitro was approved by the FDA via the 505(b) regulatory pathway using previously reported safety and efficacy data. Clinical data demonstrated that the sublingual absorption of nitroglycerin was higher following the administration of GoNitro compared to Nitrolingual Pumpspray (nitroglycerin lingual spray).

GoNitro is supplied as single dose packets of crystal granules which are placed under the tongue at the onset of an angina attack. The most common side effects include headache, dizzinesss and paresthesia.

Development timeline for GoNitro

Jun 14, 2016Approval Espero Pharmaceuticals Receives FDA Approval for GoNitro (nitroglycerin) Sublingual Powder

Further information

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