CHMP Backs Three Generics for Major Mental Illnesses

Megan Brooks

June 26, 2015

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing clearance of three generic drugs for major psychiatric disorders.

The committee recommended approval of the serotonin-norepinephrine reuptake inhibitor Duloxetine Zentiva (Zentiva Group, a.s.) for use in adults with major depressive disorder, generalized anxiety disorder, or diabetic peripheral neuropathic pain.

Duloxetine Zentiva is a generic of Cymbalta (Eli Lilly and Company), which has been on the market in the European Union since December 2004. Duloxetine Zentiva will be available as 30-mg and 60-mg gastroresistant capsules.

The EMA committee also recommended approval of the atypical antipsychotic Aripiprazole Sandoz (Sandoz), a generic version of Abilify (Otsuka Pharmaceutical Company, Ltd), which has been available in the European Union since June 2004.

Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and children aged 15 years and older; for the treatment of moderate to severe manic episodes in pateints with bipolar I disorder; for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment; and for treatment for a period of up to 12 weeks of moderate to severe manic episodes in association with bipolar I disorder in adolescents aged 13 years and older.

Aripiprazole Sandoz will be available in 5-, 10-, 15-, 20-, and 30-mg tablets.

The committee also gave a green light to the antiepileptic drug Pregabalin Accord (Accord Healthcare, Ltd), the generic version of Lyrica (Pfizer Inc), which has been authorized in the European Union since June 2004.

Pregabalin Accord is intended as adjunctive therapy for adults with partial seizures with or without secondary generalization and for the treatment of generalized anxiety disorder in adults.

Pregabalin Accord will be available in hard capsules of 25-, 50-, 75-, 100-, 150-, 200-, 225-, and 300-mg strengths.

"Studies have demonstrated the satisfactory quality" of all three generic products and their bioequivalence to the reference products, the EMA says.

Detailed recommendations for the use of these drugs will be described in the summary of product characteristics, which will be published in the Eropean public assessment report and made available after marketing authorization has been granted by the European Commission.

The US Food and Drug Administration approved the first generic versions of duloxetine in 2013 and of aripiprazole earlier this year. A generic version of pregabalin is not yet available in the United States.


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