New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

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 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 GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic/Zunrisa (Casopitant) 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 Promacta (eltrombopag) Receives Unanimous Recommendation by FDA Advisory Panel

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