FDA awards rare double approval to generic seizure drug from Amneal
HAUPPAUGE, N.Y. In an unusual dual endorsement of a new medicine, the Food and Drug Administration has approved a generic drug for the control of seizures and rated it as bioequivalent to both the original branded formulation of the drug and the leading generic version of the product.
The new product, Extended Phenytoin Sodium Capsules, USP 100 mg, is made and marketed by fast-growing generic drug maker Amneal Pharmaceuticals.
The company called the approval “an exceptional case where an Amneal generic stands as an AB-rated, therapeutically equivalent alternative to both the brand and the leading generic product.”
Added Amneal spokesperson Cheryl Lechok. “This rare FDA double approval was granted based on completion of not one but two bioequivalence studies comparing the Amneal product to the brand, Dilantin [Parke-Davis], and Mylan’s generic extended phenytoin sodium product.”
Extended phenytoin sodium is indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures, and is also used to prevent and treat seizures occurring during or following neurosurgery. Since the product has a Narrow Therapeutic Index (NTI), Amneal pursued an unusual dual path for earning approval as a therapeutically equivalent alternative to both the brand and the leading generic.
Thus, the company filed an ANDA [abbreviated new drug application] on the product for approval as a generic alternative to Dilantin, while successfully completing a second bioequivalence study of comparison to the generic extended phenytoin sodium manufactured by Mylan.
Following normal procedure, the FDA first granted approval to Amneal’s Extended Phenytoin Sodium Capsules as being AB-rated to the brand last November. “Once that approval was granted, the FDA then reviewed the second bioequivalence study and Amneal’s additional request, ultimately providing the second approval. This rare double approval by the FDA provides the critical evidence of therapeutic equivalence needed by the physician, pharmacist and patient,” noted the company.
Pfizer signs licensing agreement with Wisconsin Alumni Research Foundation
MADISON, Wis. The world’s largest drug maker has signed a licensing agreement with a patenting and licensing organization for the Univeristy of Wisconsin-Madison to use human embryonic stem cell patents to develop new drug therapies.
Pfizer said that under its agreement with the Wisconsin Alumni Research Foundation, the license will the company the rights to work with hES cells for drug research and discovery.
“Our license with WARF provides us with information and materials that will allow us to use their cell lines to explore a whole range of therapies,” Pfizer Regenerative Medicine chief scientific officer Ruth McKernan said. “Stem cells can be used to create specialized human tissue. Our scientists will determine how new medicines may be able to improve the way stem cells regenerate damaged tissues.”
GlaxoSmithKline to sell U.S. Wellbutrin XL rights to Biovail Corp.
RESEARCH TRIANGLE PARK, N.C. A drug maker announced Wednesday that it would give up U.S. rights to the extended-release formulation of a popular antidepressant.
GlaxoSmithKline said it would divest full commercial rights to Wellbutrin XL (bupropion hydrochloride) in the United States, selling it to Biovail Corp. for $510 million. Generic competition to Wellbutrin XL began at the end of 2006 for the 300-mg tablets and during the second quarter of 2008 for the 150-mg tablets. The drug had sales of $60 million in first quarter 2009.
“We are actively reshaping our U.S. business and managing the transition occurring in our product portfolio,” GSK president North American pharmaceuticals Deirdre Connelly said. “This transaction is one of a series of actions we are taking to maximize the value of our current assets and to enable us to resource and invest in new products and upcoming launches.”
Under the terms of the agreement, GSK will transfer the regulatory approval application and trademark for Wellbutrin XL to Biovail for use in the United States, though it will retain rights to the drug for other countries.