DCGI suspends Entod's marketing approval for PresVu eye drops amid misuse concerns
The DCGI suspended Entod Pharmaceuticals' approval for PresVu eye drops due to concerns over misuse and overselling of benefits, despite the company's planned October launch. Entod plans to challenge the suspension in court.
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The Drugs Controller General of India suspended Entod Pharmaceuticals' approval for PresVu eye drops due to overselling of benefits, with the company planning to challenge the suspension in court.
Indian drug regulator suspended approval of PresVu Eye Drops due to company claims of eliminating reading glasses need, which could mislead the public.
ENTOD Pharmaceuticals met with the DCGI to address concerns over PresVu eye drops, which were initially approved for treating presbyopia but had their approval suspended by the CDSCO due to unapproved claims. ENTOD's CEO clarified that PresVu is a therapeutic option, not a replacement for reading glasses, and promised to comply with all conditions. The company plans future academic sessions and training to ensure proper use of the eye drops.
The DCGI suspended Entod Pharmaceuticals' approval for PresVu eye drops due to concerns over misuse and overselling of benefits, despite the company's planned October launch. Entod plans to challenge the suspension in court.
The CDSCO suspended ENTOD Pharmaceutical's permission to manufacture and market its presbyopia eye drops due to unapproved claims. ENTOD plans to challenge the suspension in court, asserting its product's efficacy and safety based on a clinical trial. Ophthalmologists caution against the use of pilocarpine, the active ingredient, due to potential side effects and lack of long-term safety data.
Entod Pharmaceuticals plans to challenge the suspension of its PresVu eye drops by the national drug regulator, denying allegations of unauthorized promotion. The company argues that its media announcements were routine and based on DCGI approval for presbyopia treatment, similar to practices by other pharma companies.
CDSCO withdraws approval for PresVu eye drops by Entod Pharmaceuticals due to unauthorized promotion claiming reduction in dependency on reading glasses, raising safety concerns and misuse as an over-the-counter drug.
Entod Pharmaceuticals denies ethical claims or false facts about PresVu eye drops, which claimed to eliminate reading glasses for presbyopia. The DCGI suspended permission due to unapproved claims, violating New Drugs and Clinical Trial Rules. Entod plans to challenge the suspension in court, asserting their claims were based on DCGI approval and successful phase 3 trials.