Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.
Posted by Vyvanse In the News on at
Filed under Vyvanse News · Tagged with Abbreviated New Drug Application, Fda, Fda Web, Filer, Generic Drugs, Intellectual Property Rights, Lenalidomide, Mg Capsules, Notification Letter, Paragraph, Patent, Receipt, Revlimid
DUBLIN, May 28, 2010 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter today from Zydus Pharmaceuticals USA, Inc. ("Zydus") advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Shire's 1.2g mesalamine delayed release tablets, LIALDA(R).
Posted by Vyvanse In the News on at
Filed under Vyvanse News · Tagged with Abbreviated New Drug Application, Dublin, Generic Version, Lse, Nasdaq, Paragraph, Press Release, Release Tablets, Shp, Usa Inc, Zydus Pharmaceuticals
(Corrects Adderall sales in third paragraph.) April 29 (Bloomberg) -- Shire Plc said first-quarter profit fell 22 percent as a flood of generic competition to the drugmaker’s Adderall XR hyperactivity pill eroded sales.
Posted by Vyvanse In the News on at
Filed under Vyvanse News · Tagged with Adderall, Adderall Xr, April 29, Bloomberg, First Quarter, Flood, Generic Competition, Hyperactivity, Paragraph, Plc, Quarter Profit