EMA Panel Says Yes to Generic Tadalafil for ED, BPH

Megan Brooks

Disclosures

September 26, 2014

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Tadalafil Mylan (Generics UK Ltd) for the treatment of men with erectile dysfunction (ED) and benign prostatic hyperplasia (BPH).

Tadalafil Mylan is a generic of Cialis (Lilly), which has been available in the European Union since mid-November 2002.

"Studies have demonstrated the satisfactory quality of Tadalafil Mylan, and its bioequivalence with the reference product Cialis," the CHMP said.

The CHMP recommended the following indications:

  • For 2.5-, 10-, and 20-mg tablets: "Treatment of [ED] in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women."

  • For 5 mg: "Treatment of [ED] in adult males. In order for tadalafil to be effective for the treatment of [ED], sexual stimulation is required. Treatment of the signs and symptoms of [BPH] in adult males. Tadalafil Mylan is not indicated for use by women."

The CHMP recommends Tadalafil Mylan be prescribed by physicians experienced in the treatment of men with ED and signs and symptoms of BPH.

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