FDA releases list of top six generic drug approvals since March 2008

2/6/2009

ROCKVILLE, Md. Every week, the Food and Drug Administration's Center for Drug Evaluation and Research sends out an e-mail listing the latest approvals of branded and generic drugs, but some of those approvals have greater significance than others, particularly those of companies that are the first to file for regulatory approval.

The FDA released its Generic Drug Roundup Friday, listing the top six generic drug approvals since March 2008. 

* Risperidone tablets ­ a generic version of Johnson & Johnson's bipolar disorder and schizophrenia drug Risperdal, which had sales of $2.5 billionin 2007, according to Drug Store News reports.* Divalproex sodium delayed-release tablets ­ a generic version of Abbott's epilepsy, bipolar disorder and migraine drug Depakote, which had sales of $803 million for the 12 months that ended March 2008, according to IMS Health.* Ropinirole hydrochloride tablets ­ a generic version of GlaxoSmithKline's restless legs syndrome drug Requip, which had sales of $518 million in 2007, according to IMS Health.* Dorzolamide and timolol maleate ophthalmic solution ­ a generic version of Merck's ocular hypertension and glaucoma drug CoSopt, which had sales of $342 million in the 12 months that ended in June, according to IMS Health.* Galantamine oral tablets ­ a generic version of Johnson & Johnson's dementia drug Razadyne, which had sales of $102 million in the 12 months that ended in June, according to IMS Health. 

The FDA approves generic drugs under the Hatch-Waxman Act of 1984, which allows companies to market generic versions of branded drugs after the branded drugs lose patent protection. The agency gives six months of market exclusivity to the first company to file for regulatory approval of a generic drug. The Congressional Budget Office estimates that generic drugs save consumers as much as $10 billion a year. 

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