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August 21, 2014
07:38 EDTSUPN, ACTSupernus announces paragraph IV Abbreviated NDA filing for Trokendi XR
Supernus Pharmaceuticals (SUPN) announced that on August 20, the company received a Paragraph IV Notice Letter from Actavis Laboratories FL advising Supernus of the filing by Actavis (ACT) of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Trokendi XR. The product is currently protected by three issued patents that are listed in the FDA's Orange Book and expire no earlier than 2027.
News For SUPN;ACT From The Last 14 Days
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July 13, 2015
11:47 EDTACTFDA approves new drug to treat schizophrenia
The U.S. FDA announced that it has approved Rexulti tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder. Rexulti is manufactured by Tokyo-based Otsuka Pharmaceutical. Novartis' (NVS) Clozaril is indicated to treat severely ill adult patients with schizophrenia who have not responded appropriately to standard antipsychotic treatment. Other atypical antipsychotics include Otsuka's Abilify, Pfizer's (PFE) Geodon, Janssen's (JNJ) Invega and Risperdal, Forest Labs' (ACT) Saphris, AstraZeneca's (AZN) Seroquel and Eli Lilly's (LLY) Zyprexa.

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