FDA
After Ranbaxy, FDA finds gaps at Cipla PDF Print E-mail
International
Sunday, 19 April 2009 18:00

Cipla The US Food and Drug Administration (FDA) has found nine deviations in Indian drug maker Cipla’s manufacturing process during a recent inspection of the company’s Bangalore plant. The Mumbai-based company, however, said the deviations are minor ones relating to manufacturing practices.

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Sun Pharma gets nod for Roxicodone PDF Print E-mail
India State Wise
Sunday, 12 April 2009 18:00

Sun-PharmaSun Pharmaceutical Industries Ltd. on Monday announced that the US Food & Drug Administration (FDA) has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market Roxicodone, oxycodone hydrochloride tablets.

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Sun Pharma Gets U.S. FDA OK For Generic Topiramate Tablets PDF Print E-mail
India State Wise
Sunday, 29 March 2009 18:00

Sun Pharma Sun Pharmaceutical Industries Ltd. (524715.BY) has received U.S. Food & Drug Administration approval to make and sell generic versions of anticonvulsant topiramate tablets.

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Lilly's Symbyax gets US FDA approval for resistant depression PDF Print E-mail
International
Tuesday, 24 March 2009 18:00

Lilly Symbyax The US Food and Drug Administration (FDA) has approved a new indication for Symbyax (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company announced. Symbyax is now the first drug approved by the FDA for the acute treatment of treatment-resistant depression (TRD).

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