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.
Archive for the ‘Generic Drugs’ Category
FDA approves generic version of lamotrigine.
Posted in Bipolar disorder, Generic Drugs, Meds, tagged Aurobindo Pharma Ltd, bipolar med, FDA and generics, generic lamictal, generic lamotrigine, Lamictal on November 8, 2009| Leave a Comment »
FDA approves Topamax generic.
Posted in Generic Drugs, Meds, Migraines, Seizures, tagged FDA, generic Topamax, Johnson and Johnson, Teva, Topamax on October 16, 2009| Leave a Comment »
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.”
Columnist calls for increased FDA regulation of generics.
Posted in Generic Drugs, tagged FDA and generic drugs, generic drug regulation, generic meds, generic versus brand name meds on September 28, 2009| Leave a Comment »
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.