Gonitro Approved for the Treatment of Angina Pectoris
June 14, 2016 – The U.S. Food and Drug Administration (FDA) has given Espero Pharmaceuticals approval for Gonitro™ (nitroglycerin) sublingual powder. Gonitro is indicated for the acute relief of an attack or prophylaxis of angina pectoris (chest pain) due to coronary artery disease. It will be available in packets, each containing 400mcg of nitroglycerin. The recommended dose is one or two packets under the tongue at the onset of an angina attack. One additional packet can be administered every 5 minutes as needed, not to exceed three packets within a 15 minute period. The patient should seek medical attention if chest pain persists after the administration of three packets. Gonitro can also be used to prevent chest pain prior to engaging in activities that could provoke an acute angina attack. It represents another treatment option for the estimated eight million Americans who suffer with stabile angina due to coronary artery disease.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.