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FDA Approvals - US FDA clears four new generics by Indian cos (Hindustan


US FDA clears four new generics by Indian cos (Hindustan Times)
Indian drugmakers, two of which have Mumbai connections, got approvals to market four generic drugs with a cumulative market size of three and a-quarter billion dollars (Rs 15,000 crore).

MedaSorb Announces IDE Filing With the FDA; Following Approval MedaSorb Will Begin Multi-Site Pilot Study (RedNova)
MONMOUTH JUNCTION, N.J., Jan. 4, 2007 (PRIME NEWSWIRE) -- MedaSorb Technologies Corporation (OTCBB:MSBT) today announced that is has submitted an Investigational Device Exemption (IDE) Supplement to the FDA for its CytoSorb(tm) hemoperfusion blood filtration device.

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 ...
 

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