Acorda Therapeutics notified of Actavis' ANDA filing for generic Ampyra Acorda Therapeutics (ACOR) received a Paragraph IV Certification Notice Letter advising that Actavis Laboratories (ACT) submitted an Abbreviated New Drug Application - ANDA - to the FDA requesting permission to manufacture and market a generic version of Ampyra Extended Release Tablets, 10 mg. Acorda is reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Actavis Laboratories in order to trigger a statutory stay period under the Hatch-Waxman Act. This would restrict the FDA from approving an ANDA until July 2017. Ampyra is currently protected by five patents listed in the FDA’s Approved Drugs Product List. Acorda intends to vigorously defend its intellectual property rights.
FDA 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.