Pharmaceutical Business Review
Anonymous User | Login

FDA Accepts Complete Response Submitted By Johnson & Johnson For Review

Published: 01-Sep-2009

Complete Response addresses FDA's Complete Response Letter concerning ceftobiprole for complicated skin and skin structure infections

Basilea Pharmaceutica ( Basilea) has reported that the FDA has accepted the complete response submitted by the Johnson & Johnson.

The Complete Response submission addresses the FDA Complete Response Letter issued in November 2008 concerning the ceftobiprole NDA for complicated skin and skin structure infections.

Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea and Cilag, a Johnson & Johnson company.

Anthony Man, CEO at Basilea, said: The FDA informed Johnson & Johnson that it considers the resubmission a complete, class 2 response. We are pleased that the FDA has accepted for review the submission related to the Complete Response Letter. We look forward to the advancement of ceftobiprole through the FDA review process.

Share

Mail sent successfully

Tell your friend about this article


Please enter a valid email address

Please enter your name

Please enter the mail body


Your Name: *
Your Email: *
Friend's Email: *
Email Body: *
 

Suppliers To This Sector

Browse A-Z

# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Almac

Drug Development Solutions ...

STARLIMS

Benefits for Life Science Labs ...

Parenteral Drug Association (PDA)

Pharmaceutical Information and Education Services ...

Burkert Fluid Control Systems

Fluid and Gas Control Systems ...

IMCOR

LIMS and Laboratory Informatics Consultancy ...

Umicore Precious Metals Chemistry

Chemicals and Catalysts for Industrial Applications ...

White Papers

Browse A-Z

# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

GRACO's New FDA Pumps

The Graco 3150 3A sanitary pump is designed to meet the stringent sanitation requirements ...

GRACO's New Hydra-Clean

The Graco 3150 3A sanitary pump is designed to meet the stringent sanitation requirements ...

GRACO's New 1590 & 3150 Pumps

The Graco 3150 3A sanitary pump is designed to meet the stringent sanitation requirements ...

Water Treatment

From the control room to the downstream processing area and with an eye on utilities servi ...

Customer Testimonial – Astra Zeneca

From the control room to the downstream processing area and with an eye on utilities servi ...

Hygienic Processing

From the control room to the downstream processing area and with an eye on utilities servi ...

Related Companies

Zimmer Holdings, Inc.

Zimmer Holdings, Inc. (Zimmer) is engaged in the design, development, manufacture, and ...

Biomet, Inc.

Biomet, Inc. (Biomet) is engaged in the design, manufacture and marketing of products u ...

Smith & Nephew Plc

Smith & Nephew Plc (Smith & Nephew) is a global medical devices company, engaged in the ...

Merck & Co., Inc.

Merck & Co., Inc. (Merck) is a global research-driven pharmaceutical company engaged in ...

Abbott Laboratories

Abbott Laboratories (Abbott) is a global health care company. It is principally engaged ...

Suppliers Product News

Almac Completes Phase One of Its Expansion Plan to Pharma Services Facilities

New $15m facility will "meet growing business need for its integrated product development and commercial services."

Free Newsletter Sign-up

Sign up, and we will send you a free Pharmaceutical report on “ Combination Products – Evolution of the Medical Equipment Industry” from GlobalData worth $750

Please enter a valid email address