Eisai Inc. has announced that the FDA has accepted for review Eisai’s NDA for BANZEL® (rufinamide) Oral Suspension (40 mg/mL). The proposed indication is for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older and adults. The application is based on data from a study designed to demonstrate the bioequivalence of the oral suspension formulation to the currently marketed BANZEL tablet formulation (400 mg).

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Lundbeck Inc has received approval from the FDA for its two New Drug Applications (NDA), Sabril (vigabatrin) Tablets and Oral Solution. Lundbeck will be launching Sabril in the US during the third quarter. Sabril is indicated as a monotherapy for pediatric patients, aged between one month and two years, with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss. The drug is also indicated as an add-on therapy for adult patients with refractory complex partial seizures who have failed other available treatments and for whom the potential benefits outweigh the risk of vision loss.

Johnson & Johnson Pharmaceutical Research & Development has submitted an NDA (New Drug Application) for its tapentadol hydrochloride immediate release (IR) tablets to the FDA. Tapentadol is an investigational oral analgesic for treating moderate to severe acute pain. Clinical studies show that tapentadol has efficacy comparable to strong opioids. Over 25 million Americans suffer from acute pain every year, according to the American Pain Foundation.