FDA Approvals - Lupin Pharmaceuticals Announces Tentative Approval of Generic ZOLOFT(R) (RedNova) BALTIMORE,
Lupin Pharmaceuticals Announces Tentative Approval of Generic ZOLOFT(R) (RedNova)
BALTIMORE, Jan. 2 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg.
DURECT Starts Phase II Dosing for TRANSDUR(TM)-Bupivacaine (DUR-843) (FinanzNachrichten)
CUPERTINO, Calif., Jan. 3 /PRNewswire-FirstCall/ -- DURECT Corporation ( Nachrichten ) today announced that we have started Phase II dosing in the U.S. under an FDA-accepted Investigational New Drug (IND) application for TRANSDUR(TM)-Bupivacaine (DUR-843), a transdermal pain patch for patients suffering from Post-Herpetic Neuralgia (post-shingles pain or PHN). DURECT's Phase I trial for ...