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Laurus Labs receives USFDA approval for two ANDA's TLE 400 & TLE 600 tablets

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Laurus Labs has received an approval from USFDA under PEPFAR (President's Emergency Plan for AIDS Relief) for two ANDAs (Abbreviated New Drug Application) TLE 400 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/400mg) and TLE 600 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/600mg) tablets.

Laurus Labs is one of the few players in the ARV segment to receive an approval for TLE 400 tablets.

TLE 400 is one of the most preferred regimens in the ARV first line treatment. The Company already received WHO Pre-Qualification for TLE 400 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/400mg).

These approvals enables Laurus Labs to launch both the products in several LMIC markets.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, May 19 2020. 16:45 IST
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