What brand of ED medication did SS Pharmaceutical receive OTC approval for in Japan?

SS Pharmaceutical received OTC approval for the ED medication Cialis® in Japan.

Which company obtained approval to market Cialis® as an OTC drug in Japan?

SS Pharmaceutical Co., Ltd. obtained approval to market Cialis® as an OTC drug in Japan.

What is the significance of Cialis® receiving approval in Japan on this date?

Cialis® became the first ED treatment drug approved as an OTC medication requiring instruction in Japan.

What type of pharmaceutical classification does Cialis® now have in Japan under SS Pharmaceutical?

Cialis® is now classified as an over-the-counter drug requiring instruction in Japan.

How does the approval of Cialis® by SS Pharmaceutical impact ED treatment access in Japan?

The approval allows easier access to ED treatment without a prescription in Japan.

SS Pharmaceutical Obtains Approval for ED Drug 'Cialis®' as an OTC Medication in Japan

Published May 20, 2026 7:25 PM ・ Updated Jun 14, 2026 2:33 PM ・ 3 min read ・ Source: PR TIMES

SS Pharmaceutical Co., Ltd. announced that it has obtained manufacturing and marketing approval for the ED treatment drug 'Cialis®' as an over-the-counter (OTC) medication (drug requiring instruction) in Japan for the first time.

SS Pharmaceutical Obtains Approval for ED Drug 'Cialis®' as an OTC Medication in Japan

SS Pharmaceutical Co., Ltd. (Headquarters: Shinjuku, Tokyo; President: Yoko Motoshima) announced that it has received manufacturing and marketing approval for the ED medication 'Cialis®' as an over-the-counter (OTC) drug.

'Cialis®' is an ED treatment that supports erection and maintenance only when sexual stimulation occurs; it is not a vitality booster or libido enhancer. Cialis® tablets, as a prescription medication, have been used in over 100 countries for over 20 years. Celebrating its 20th year of clinical use in Japan, this approval marks its first offering as a 'Switch OTC' drug, available with appropriate information provided by pharmacists.

### Product Information - Product Name: Cialis® - Category: Drug requiring instruction (OTC) - Active Ingredient: Tadalafil 10mg - Indication: Erectile Dysfunction - Dosage: Adult males (18+) should take one tablet approximately one hour before sexual activity with water or lukewarm water. Do not exceed one tablet per day, and wait at least 24 hours between doses.

### Background Large-scale surveys suggest that approximately one in two Japanese men may experience ED. However, stigma and misconceptions often hinder appropriate treatment choices. Additionally, there are risks associated with counterfeit drugs from unauthorized online imports. Through this OTC switch, SS Pharmaceutical aims to foster an environment where men can make informed choices based on correct knowledge.

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Source: PR TIMES
Category: New Product

SS Pharmaceutical Obtains Approval for ED Drug 'Cialis®' as an OTC Medication in Japan

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SS Pharmaceutical Obtains Approval for ED Drug 'Cialis®' as an OTC Medication in Japan

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