generic

FDA Approves Lupin’s Generic Form of Tecfidera for MS Treatment

Lupin‘s generic equivalent ofĀ Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment ofĀ multiple sclerosis (MS), the company announced in a press release. The therapy ā€” dimethyl fumarate delayed-release capsules ā€” is indicated for use in people withĀ clinically…

Mylan Launching Tecfidera Generic in US

Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS). The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid ā€”…

Generic Version of Gilenya, pms-Fingolimod, Now Available for RRMS Patients in Canada

PharmascienceĀ recently launched pms-Fingolimod, a generic version of Novartisā€™Ā GilenyaĀ (fingolimod),Ā to treat adults with relapsing-remitting multiple sclerosisĀ (RRMS) in Canada. The new generic is now available in that country, and has demonstrated efficacy and safety similar to Gilenya. GenericĀ medicines are chemically identical to the original branded therapy, but carry a…

A Generic for Ampyra Could Be Released Soon

Editorā€™s note: Shortly after this column was published, Mylan pharmaceuticals announced it will begin distributing Dalfampridine Extended-Release Tablets, 10 mg, the authorized generic version of Acordaā€™s Ampyra. Thereā€™s been no word, yet, on what it will cost or how soon the generic will become available in pharmacies. A few…

Generic Form of Copaxone, GTR, Safe and Effective, Study Confirms

An extension trial assessing generic glatiramer acetate (GTR) treatment in multiple sclerosis (MS) patients found that the formulation is as safe and effective as Copaxone (branded glatiramer acetate), and that switching to GTR is well-tolerated. The findingsĀ were in theĀ study, ā€œSwitching from branded to generic glatiramer acetate:…

Generic Form of Glatiramer Acetate Has Equivalent Gene Expression Profile as Teva’s Copaxone

In a recent study entitled ā€œEquivalent Gene Expression Profiles between Glatopaā„¢ and CopaxoneĀ®,ā€ authors determined potential differences in treatment responses by investigating the gene expression profile of two approved treatments for relapsing forms of multiple sclerosis ā€“ Copaxone and Glatopa. Both of these MS therapies are glatiramer…

Pfizer Acquires Exclusive Commercialization Rights to Generic Copaxone for Relapsing Remitting Multiple Sclerosis

Netherlands-based international pharmaceutical company Synthon, best known for developing complex generic therapeutics, has officially entered into an agreement with pharmaceutical giant Pfizer, Inc., effectively transferring the exclusive rights in the US to glatiramer acetate to Pfizer. Glatiramer acetate is an experimental generic formulation of Copaxone, which is indicated as a…