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  • Eye drops late to submit test results pass reivew
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Apr 4, 2024 05:59am
Received administrative dispositions due to late submission of bioequivalence test results
MFDS releases drug equivalence reevaluation results
Daewoo Pharm demonstrates equivalence of its eye drops after receiving administrative disposition
Amid the ongoing equivalence reevaluations being conducted on eye drops, products that received dispositions for failing to submit equivalence data in time received a final compliant decision.

The Ministry of Food and Drug Safety (MFDS) released the results of the ¡®2022 drug equivalence reevaluation¡¯ that contained such results on the 3rd.

The third list included 4 suspension eye drops, and Daewoo Pharm, which was in charge of the consignment manufacture of the drugs, received a ¡®compliant¡¯ judgment, and the other consigned items were also judged compliant and approved.

More specifically, the items approved this time are Daewoo Pharm¡¯s ¡®Tobeson Eye Drops (exported as Philtobeson Eye Drop, Dextear Eye Drop)
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