PHARMACY

Ocuflox generic gets FDA approval

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved Sandoz’s generic version of Allergan’s Ocuflox, FDA records show.

The agency approved the generic ofloxacin eye drops by Novartis’ generics subsidiary on Tuesday. 

About 15 other companies also make generic versions of Ocuflox, a treatment for bacterial infections in the eye.

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FDA grants tentative approval for generic version of Zyprexa

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has granted tentative approval to Roxane Labs’ generic version of Eli Lilly and Co.’s antipsychotic drug, Zyprexa, FDA records show.

The FDA passed tentative approval for the generic version of the drug in the 5 mg strength Nov. 20.

Several other drug makers, such as Teva, Mylan, Sandoz and Barr Labs, also are developing generic versions of Zyprexa.

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Approval application withdrawn by Eli Lilly

BY Alaric DeArment

INDIANAPOLIS Eli Lilly and Co. has withdrawn an application seeking approval from the Food and Drug Administration to market its antidepressant Cymbalta for treating chronic pain, the Indianapolis-based drug maker said Friday.

Citing a need for more data, Lilly said it plans to resubmit the application in the first half of next year for the added use of the drug.

“This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application,” vice president of Lilly Research Laboratories John Hayes said in a statement.

Cymbalta (duloxetine hydrochloride) is already approved for treating depression, anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia.

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