FDA approves generic version of lamotrigine.

Dow Jones Newswire ( 11/6  http://tinyurl.com/generic-lamictal) reports, “Aurobindo Pharma Ltd. said Friday it has received the final approval from the US Food and Drug Administration for selling a generic version of the epilepsy” medication lamotrigine [Lamictal]. The FDA approval “is for 5-milligram and 25-mg tablets.” GlaxoSmithKline manufactures the brand name version of the medication.

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Senate Judiciary Committee passes bill to prevent drugmakers from delaying generics.

CQ Today (10/16, Vadala) reports, “The Senate Judiciary Committee on Thursday approved legislation [S 369] that would prevent pharmaceutical companies from negotiating to delay the introduction of generic versions of drugs into the market.” The panel passed the measure, sponsored by Sen. Herb Kohl (D-WI), “by a vote of 12-7.” The bill “would target settlements between brand name drug companies and generics manufacturers in patent disputes,” which “often include agreements to delay generic versions of prescription drugs in exchange for payments from the brand name company to the generics manufacturer.” The bill also would provide “drug companies the opportunity to prove in court that they are not acting in an anti-competitive fashion,” but it would require companies to prove “with ‘clear and convincing’ evidence that the agreements promote competition.”

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FDA approves Topamax generic.

The AP (10/15) reported, “Mylan Inc. said Thursday it received regulatory approval for its version of Johnson & Johnson’s epilepsy drug Topamax [topiramate], and began shipping” the “15 milligram and 25 milligram topiramate sprinkle capsules.” The patents “on Topamax expired in March,” and the AP notes that “Teva Pharmaceutical Industries Ltd. also markets a generic version of the drug.”

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Columnist calls for increased FDA regulation of generics.

In a column in the San Francisco Chronicle (9/28, A11), Phil Bronstein writes that some psychiatrists have “found in the last few months that a number of their patients on newer generic versions of” psychotropic medications had “regressive episodes of anxiety [and] insomnia.” In some cases, however, when patients “were switched from generics back to the brand names, their symptoms went away.” Bronstein notes, “The Food and Drug Administration, which does the monitoring, has a lot more work to do as generics manufacturers proliferate around the world.” But, agency spokeswoman Sandy Walsh said that “the notion of a measurable difference between the originals and generics is ‘a big myth.'” Still, according to Alan Schatzberg, MD, head of Stanford’s psychiatry department, “The agency ‘doesn’t require the same efficacy’ from a generic” medication “as it does from a brand name.” Bronstein concludes, “The FDA needs to amp up its vigilance” of generics.

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