Warner Chilcott Company, Inc. announced today that it has received a Paragraph IV Certification Notice from Watson Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of LOESTRIN(R) 24 FE.
Drug
Newswire
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Kyowa Kirin’s Poteligeo Gains European Marketing Authorization
Poteligeo is the first biologic agent targeting CCR4 to be approved in Europe.
FDA Releases Proposed Rule on De Novo Pathway for Novel Devices
FDA Commissioner Scott Gottlieb said the agency’s goal is “to make the De Novo pathway significantly more efficient and transparent.”
FDAnews Drug Daily Bulletin
WARNER CHILCOTT ANNOUNCES RECEIPT OF PARAGRAPH IV CERTIFICATION NOTICE
June 28, 2006
