FDA approves oral suspension of Eisai’s Fycompa
SILVER SPRING, Md. — The Food and Drug Administration has approved Eisai’s Fycompa (perampanel) oral suspension, the company announced Monday. The oral suspension has been approved to treat partial-onset seizures with or without secondary generalized seizures, as well as for primary generalized tonic-clinic (PGTC) seizures in patients with epilepsy older than 12.
“We are excited about the approval of FYCOMPA Oral Suspension, as it gives another option to patients with epilepsy who may have difficulty swallowing tablets or prefer liquids,” said Dr. Lynn Kramer, Eisai’s chief clinical officer and chief medical officer of its neurology business group. “The development of this new formulation underscores Eisai's commitment to advancing epilepsy care by making contributions to help address the diversified needs of epilepsy patients and their families.”
The new oral formulation is interchangeable with the company’s Fycompa tablets, and Eisai expects to make it available in June. The drug comes with a boxed warning for serious psychiatric and behavioral reactions.
Perrigo launches generic BenzaClin Pump
DUBLIN — Perrigo on Monday announced the FDA approval and launch of its generic BenzaClin (clindamycin phosphate 1% and benzoyl peroxide 5%) Pump topical gel.
The drug is indicated to treat acne vulgaris, and the company has already begun shipping to customers.
“This Rx product approval and launch demonstrate the team's ability to leverage Perrigo's manufacturing expertise in order to provide our customers with the latest technologies,” Perrigo CEO John Hendrickson said. “Providing our customers with convenient, cost effective technologies like the BenzaClin Pump furthers Perrigo's commitment of delivering quality affordable healthcare products around the world.
FDA approves first Crestor generic
SILVER SPRING, Md. — The Food and Drug Administration on Friday announced that it had approved a generic of AstraZeneca’s Crestor (rosuvastatin calcium). The generic, from Allergan, is the first to be approved for blockbuster Crestor, which saw $6.5 billion in annual sales for the 12 months ended March 31, according to IMS health.
The drug is indicated to treat high triglycerides, dysbetalipoproteinemia and high LDL cholesterol. It was approved in 5-, 10, 20-, and 40-mg dosage strengths, according to the FDA.
“The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments,” said Dr. Kathleen Uhl, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.
In 2013, Actavis said it would launch its generic 67 days before July 8 — the day that Crestor’s pediatric exclusivity expires.
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