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June 30, 2014
07:30 EDTACTActavis confirms generic Zubsolv patent challenge
Actavis confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv, which is a partial opioid agonist indicated for the maintenance treatment of opioid dependence. Orexo AB and Orexo US, Inc. filed suit against Actavis on June 26, 2014, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. Patents.
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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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