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FDA Accepts NDA For Topical Estrogen Replacement Therapy.(Brief Article)
2001 OCT 18 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has accepted for filing Novavax Inc.'s New Drug Application (NDA), submitted on June 29, 2001, for ESTRASORB (17-beta-estradiol) lotion. The acceptance indicates that the FDA has found Novavax's NDA to be sufficiently complete to permit a substantive review.
Under the terms of Novavax's agreement with King Pharmaceuticals Inc. (KG), the company's U.S. copromotion partner for ESTRASORB, Novavax has received a $2.5 million milestone payment from King, due upon the FDA's formal acceptance of the ESTRASORB NDA filing. This milestone is in addition to the $2.5 million received when the NDA was submitted. The company also expects to receive an additional $5 million from King shortly. This represents the remaining portion of the $25 million convertible debenture investment committed in December 2000. The conversion price of the note is $10 per share, which was an 18% premium to the trailing 20-day average stock price prior to the closing in December 2000. Furthermore, King plans to close on an additional $5 million convertible ...
- Novavax's ESTRASORB Product Referenced on NBC's 'Today Show'.
- Press release article from: PR Newswire January 10, 2005 700+ words
Novavax, Inc. , a specialty pharmaceutical...Today" this morning referenced Novavax's ESTRASORB(R) product, a topical estrogen...including hormones. In addition to ESTRASORB(R), Novavax has several product candidates utilizing...
- Novavax Completes ESTRASORB Partnership - Part 1.
- News wire article from: The America's Intelligence Wire October 1, 2005 700+ words
...gentlemen, and welcome to the Novavax Esprit ESTRASORB extraction conference call...exclusive license to market ESTRASORB in North America. Our company, Novavax, will continue to manufacture ESTRASORB in our state-of-the-art...
- Novavax Submits New Drug Application for ESTRASORB(TM), A Topical Estrogen...
- Press release article from: PR Newswire June 29, 2001 700+ words
...symptomatic menopausal women. ESTRASORB, which employs Novavax's proprietary micellar...as described above for ESTRASORB. Likewise, King and Novavax will exclusively co...strong commitment to both Novavax and ESTRASORB," stated John A. Spears...
- Novavax Completes ESTRASORB Partnership.
- Press release article from: PR Newswire October 18, 2005 700+ words
...exclusive rights to market ESTRASORB in North America. Novavax will continue to manufacture ESTRASORB in its state-of-the...determined net sales levels of ESTRASORB. This transaction today allows Novavax to continue to realize potential...
- Novavax Expands Licensing Agreement With King Pharmaceuticals For ESTRASORB(TM)...
- Press release article from: PR Newswire June 29, 2001 700+ words
...NYSE: KG) for ESTRASORB(TM), Novavax's proprietary topical...commitment to both Novavax and ESTRASORB. Their continued...candidate, and employs Novavax's proprietary micellar...MNP) technology. ESTRASORB's MNP formulation...
- King Pharmaceuticals Announces Exclusive License for Estrasorb(TM) with Novavax.
- Press release article from: PR Newswire January 8, 2001 700+ words
...distribute and sell Estrasorb(TM), Novavax's topical, transdermal...territory. King and Novavax will co-market Estrasorb(TM) in the United...shall pay $5 million to Novavax if the NDA for Estrasorb(TM) is accepted for...
- Novavax Enters Into Estrasorb(R) Asset Sale and Supply Agreements with Graceway...
- Press release article from: PR Newswire February 19, 2008 700+ words
...equipment related to Estrasorb. Graceway granted back to Novavax a royalty-free...fields unrelated to Estrasorb. Under the supply agreement, Novavax will manufacture...ongoing production of Estrasorb will generate for Novavax only a modest profit...
- Novavax's Launch of ESTRASORB(R) Underway.
- Press release article from: PR Newswire April 21, 2004 700+ words
...promotion to physicians. Novavax continues to receive encouraging feedback about ESTRASORB from both physicians...24,000 square foot ESTRASORB manufacturing and packaging...Philadelphia, Pennsylvania. ESTRASORB is Novavax's first product utilizing...
- Independent Research Study Shows Significant Interest in New FDA Approved...
- Press release article from: PR Newswire May 3, 2004 700+ words
...said Nelson M. Sims, President & CEO of Novavax. "ESTRASORB is Novavax's first product utilizing a proprietary micellar...a lotion-like treatment. About ESTRASORB ESTRASORB is Novavax's first product utilizing its proprietary...
- Novavax, Inc. Enters into Long-Term Lease Agreement with Division of Cardinal...
- Press release article from: PR Newswire February 11, 2002 700+ words
...produce and package Novavax's novel estrogen replacement lotion, ESTRASORB(TM), for which...in August 2001. ESTRASORB(TM) utilizes Novavax's patented micellar...to partner with Novavax in bringing ESTRASORB(TM) to market...
Source: HighBeam Research, FDA Accepts NDA For Topical Estrogen Replacement Therapy.(Brief...