Tag Archives: nda

VIEW ALL

Merck Announces FDA Acceptance of New Drug Application for Investigational Ophthalmic

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Mar 9, 2011 – Merck, known as MSD outside the United States and Canada,announced today that the New Drug Application…
Continue reading

FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the T

PRINCETON, N.J. & LONDON–(BUSINESS WIRE)–Mar 8, 2011 – Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug oeffentliche Hand…
Continue reading

Merck Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Appli

DARMSTADT, Germany, March 2, 2011 ? Merck Kommanditgesellschaft auf Aktien announced today that it received a complete response letter from the FDA on…
Continue reading

FDA Accepts Lundbeck Inc. Submission of New Drug Application for Clobazam

DEERFIELD, Ill.–(BUSINESS WIRE)–Mar 4, 2011 – Lundbeck Inc. today announced the U.S. Food and Drug Administration (FDA) has accepted for review a New…
Continue reading

FDA Denies Taliglucerase Alfa New Drug Application

February 25, 2011 – On Friday morning, Protalix BioTherapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has issued a Complete…
Continue reading

US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets)

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor T

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

VIVUS Provides Regulatory Update on Qnexa NDA

MOUNTAIN VIEW, Calif., Jan. 21, 2011 /PRNewswire/ — VIVUS, Inc. today announced that it held an End-of-Review meeting with the Food and Drug…
Continue reading

Adventrx Pharmaceuticals Receives PDUFA Date for Exelbine NDA

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato

MOUNTAIN VIEW, Calif., Jan. 18, 2011 /PRNewswire/ — Alexza Pharmaceuticals, Inc. announced today that it completed an End-of-Review meeting with the U.S. Food…
Continue reading

MannKind Corporation Receives Complete Response Letter from the FDA for Afrezza

VALENCIA, Calif.–(BUSINESS WIRE)–Jan 19, 2011 – MannKind Corporation today announced that it has received a complete response letter from the U.S. Food &…
Continue reading

U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

Transcept Pharmaceuticals Resubmits Intermezzo New Drug Application for the Treatment

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading
 

Facebook

    Subscribe Contact Me Popular Social
 
Thank you for subscription!
 
Thank you! Your message has been submitted to us.