FDA Approvals - Oxygen Biotherapeutics, Inc. Submits Request For Designation To FDA For
Oxygen Biotherapeutics, Inc. Submits Request For Designation To FDA For Oxycyte(R)-based Wound Care Product (Medical News Today)
Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) announced that the company has submitted a preliminary Request For Designation (RFD) to the FDA for its first wound care product. The RFD submission is part of a process with the FDA for determining which agency component will have primary jurisdiction for a drug, device or biological product.
Mylan receives final FDA approvals for generic Lamictal tablets (News-Medical-Net)
Mylan Inc has announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine Tablets.
U.S. FDA Approves Oraquick Advance(R) 12-Month Shelf Life Dating (Medical News Today)
OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that the United States Food and Drug Administration (FDA) has approved its request for 12-month shelf life from the date of manufacture for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.