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Estrasorb accepted for review by the FDA.(Novavax Inc. )(Brief Article)
2003 JAN 2 - (NewsRx.com & NewsRx.net) -- Novavax, Inc., (NVAX) announced that the U.S. Food and Drug Administration (FDA) has accepted its new drug application (NDA) for Estrasorb for review.
The company resubmitted its NDA for Estrasorb on September 9, 2002, less than 5 months after voluntarily withdrawing the filing in April 2002 after the FDA requested additional information with respect to the company's initial NDA filing. Estrasorb, an estradiol topical emulsion, is an estrogen-only lotion-like formulation being developed for short-term use in the reduction of vasomotor symptoms, such as hot flushes, in menopausal women.
"We are very pleased that our NDA resubmission has been accepted for review by the FDA and we look forward to working closely with the agency ...
- Novavax's Enters Final Phase of Its Commercial Launch of ESTRASORB(R).
- Press release article from: PR Newswire June 22, 2004 700+ words
...receiving their initial stocking orders for ESTRASORB. Novavax sales representatives are beginning full product...easy to fit into their daily routine." About ESTRASORB ESTRASORB is Novavax's first product utilizing its proprietary...
- Novavax to reacquire all rights to Estrasorb from King Pharmaceuticals.
- News wire article from: Asia Africa Intelligence Wire July 19, 2004 700+ words
...promotion agreement for Estrasorb (estradiol topical emulsion) enabling Novavax to reacquire all...marketing and promoting Estrasorb. In return, Novavax will pay King $22...worldwide rights to Estrasorb. Novavax anticipates the receipt...
- 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'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...
- Novavax to Reacquire All Rights to ESTRASORB(R) From King Pharmaceuticals.
- Press release article from: PR Newswire July 19, 2004 700+ words
...marketing and promoting ESTRASORB. In return, Novavax will pay King $22 million...the worldwide rights to ESTRASORB. Novavax anticipates the receipt...equipped to actively promote ESTRASORB." Novavax Investor Conference Call...
- Novavax and King Pharmaceuticals Announce FDA Approval of Estrasorb(TM); First...
- Press release article from: PR Newswire October 10, 2003 700+ words
...agents. With FDA approval of ESTRASORB, Novavax joins an elite group of biopharmaceutical...the marketing prospects for ESTRASORB." Novavax and King will co-promote...drugs." About ESTRASORB ESTRASORB employs Novavax's proprietary Micellar...
- Novavax, Inc. Clarifies Recent Form S-3 Registration Statement Filings and...
- Press release article from: PR Newswire August 18, 2004 700+ words
...connection with Novavax's repurchase...worldwide rights to ESTRASORB and related financings...23 million to Novavax's balance sheet to support the ESTRASORB launch and sales...In addition to ESTRASORB(R), Novavax has several product...
- 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...
- FDA Accepts Novavax's New Drug Application for ESTRASORB(TM), a Topical...
- Press release article from: PR Newswire September 5, 2001 700+ words
...s U.S. co-promotion partner for ESTRASORB, Novavax has received a $2.5 million milestone...fund pre-launch marketing expenses for ESTRASORB. Novavax and King will co-promote ESTRASORB in the U.S. and Puerto Rico, while...
- Novavax Re-Acquires Rights to Estrasorb - Final.
- News wire article from: Fair Disclosure Wire July 19, 2004 700+ words
...agreement with King are now gone and ESTRASORB remains Novavax property regardless of any future relationships...ends the copromoted agreement between Novavax and King for ESTRASORB as well as ANDROSORB. Novavax also regains as I previously mentioned...
Source: HighBeam Research, Estrasorb accepted for review by the FDA.(Novavax Inc. )(Brief...