New Drug Applications Archive

New Drug Applications: May 2008

May 1	Pro-Pharmaceuticals Updates NDA Filing for Davanat
May 2	Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS
May 2	Lev Announces FDA Advisory Committee Unanimously Recommends Approval of Cinryze for Hereditary Angioedema
May 5	Discovery Labs Provides Guidance On FDA Approvable Letter for Surfaxin for RDS
May 6	Lev Pharmaceuticals Announces Cinryze Complete Response Submission Accepted for Review by FDA
May 9	Adolor Provides Regulatory Update on Entereg (alvimopan)
May 15	Orexo Has Submitted the Registration Application for Sublinox (OX22) to the FDA
May 16	Arpida Announces FDA Acceptance of the Iclaprim New Drug Application
May 19	Ipsen and Medicis Announce Acceptance of Reloxin BLA in Aesthetics by FDA
May 20	Pro-Pharmaceuticals Announces Submission of Drug Master File for Davanat to FDA
May 27	Wyeth Receives Approvable Letter From FDA for Bazedoxifene for the Treatment of Postmenopausal Osteoporosis
May 28	Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing by FDA for the Treatment of Overactive Bladder
May 29	Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in Surfaxin Approvable Letter
May 29	GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic/Zunrisa (Casopitant)
May 29	Wyeth Receives Approvable Letter from FDA for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
May 30	Novo Nordisk Files for Regulatory Approval of Liraglutide in Both the US and Europe
May 30	Promacta (eltrombopag) Receives Unanimous Recommendation by FDA Advisory Panel

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