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Espero Pharmaceuticals Announces FDA Acceptance of New Drug Application for GoNitro™

Wednesday, November 4, 2015   (0 Comments)
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Espero Pharmaceuticals Announces FDA Acceptance of New Drug Application for GoNitro™ (Nitroglycerin Powder for Sublingual Use)

 

JACKSONVILLE, Fla.--(BUSINESS WIRE)--Espero Pharmaceuticals, Inc., (http://www.esperopharma.com) a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for GoNitro™ for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

 

"The FDA's acceptance for review of this application for nitroglycerin powder for sublingual use represents a key milestone in advancing treatment options and benefits to individuals with this critical cardiovascular condition," said Quang Pham, CEO. "This novel presentation represents the first product innovation in this category in nearly 20 years."

 

The product was developed by Pohl-Boskamp, a fully-integrated German pharmaceutical company with a 175 year operating history. Espero has an exclusive Licensing and Distribution Agreement with Pohl-Boskamp in the U.S. market and is supporting the submission of this NDA to the FDA. A proven innovator in the nitroglycerin category, Pohl-Boskamp is also the owner of the NDA for Nitrolingual® Pumpspray approved by FDA in 1997.

 

The FDA has set an action date of June 10, 2016 to complete its review, as per the Prescription Drug User Fee Act (PDUFA).

 

About Espero

Espero Pharmaceuticals, Inc., headquartered in Jacksonville, Florida, is an emerging growth specialty pharmaceutical company engaged in maximizing the commercial value of proven treatments that improve the quality of life for patients. Espero is focused on compounds with proven safety and efficacy administered via novel delivery solutions in the cardiovascular and other specialty therapeutic categories.

 

About G. Pohl-Boskamp GmbH & Co KG

Pohl-Boskamp is a privately owned business active in the international pharmaceutical market for 175 years with commercialized products in more than 45 countries. Through close collaboration with its partners abroad, Pohl-Boskamp focuses on developing and marketing products that positively impact patients' quality of life. It operates in numerous healthcare sectors including pneumology, urology, parasitology, cardiovascular diseases, gastroenterology, sleep disorders and dermatology. For more information visit http://www.pohl-boskamp.com/en/.

 

Contacts

MBS Value Partners, LLC
Betsy Brod / Jane Searle
212-661-2231
betsy.brod@mbsvalue.com


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