![]() ![]() The company is requesting that the agency reconsider its departure from its longstanding general rule of requiring clinical endpoint bioequivalence studies for locally acting generic drug products, including those that reference LIDODERM. With respect to Endo's regulatory approach, the company submitted a Citizen Petition in 2006 in reaction to a proposal by FDA's Office of Generic Drugs that would diverge from applicable regulations and standards of practice regarding bioequivalence. Food and Drug Administration's (FDA) Orange Book and expires in October 2015. 5,827,529, which covers the formulation of LIDODERM, a topical patch to relieve the pain of postherpetic neuralgia launched in 1999. The Paragraph IV certification notice refers to U.S. Endo intends to vigorously defend LIDODERM's intellectual property rights and pursue all available legal and regulatory pathways in defense of LIDODERM. The company is currently reviewing the details of this notice from Watson. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of LIDODERM®( )(lidocaine topical patch 5%). ![]() have received a Paragraph IV Certification Notice from Watson Laboratories, Inc. 19 /PRNewswire-FirstCall/ - Endo Pharmaceuticals (Nasdaq: ENDP) announced today that its partners, Teikoku Seiyaku Co., Ltd. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |