PHARMACY

FDA gives OK for Glucophage generic

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved Indicus Pharma’s generic version of Bristol-Myers Squibb’s Glucophage, FDA records show.

The FDA approved Indicus’ generic metformin hydrochloride tablets in 500 mg, 850 mg and 1 g strengths. The drug is used to lower blood sugar in patients with Type 2 diabetes.

Nearly 30 companies market generic versions of Glucophage.

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Approval application withdrawn by Eli Lilly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INDIANAPOLIS Eli Lilly and Co. has withdrawn an application seeking approval from the Food and Drug Administration to market its antidepressant Cymbalta for treating chronic pain, the Indianapolis-based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