In an 8-K filing with the Securities and Exchange Commission
(SEC) dated Aug 21, 2013,
Supernus Pharmaceuticals, Inc.
) disclosed its commercial supply agreement with Catalent Pharma
Solutions, LLC. The parties joined forces effective Dec 15, 2012,
in anticipation of final approval for Trokendi XR in the U.S.
Supernus received final U.S. Food & Drug Administration (FDA)
approval on Aug 16, 2013.
Commercial-grade quantities of topiramate, the main ingredient
required for Trokendi XR, will be manufactured and provided by
Catalent under the agreement.
Catalent will manufacture Trokendi XR as per mutually agreed
upon specifications and current good manufacturing practices.
Besides this, Catalent will also be responsible for processing,
packaging and labeling of Trokendi XR. Supernus will provide the
active pharmaceutical ingredient and materials required for
manufacturing Trokendi XR.
Trokendi XR is approved for the treatment of epilepsy. A
request for final approval was filed in Dec 2012 along with a
safety data update, a new package insert and packaging
configurations for Trokendi XR.
Trokendi XR is a novel once-daily extended release formulation
Johnson & Johnson
)'s Topamax (topiramate). This epilepsy product will be launched
in a few weeks.
Along with granting approval, the FDA also agreed to a
deferral of submission of post-marketing pediatric
pharmacokinetic assessments, which were due in 2019, followed by
clinical assessments in 2025. Supernus also got an FDA waiver for
certain pediatric study requirements.
Supernus carries a Zacks Rank #1 (Strong Buy). Currently,
Acura Pharmaceuticals Inc.
) are also performing well, with both being Zacks Rank #2 (Buy)
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