Laurus Labs gets USFDA endorsements for ANDAs TLE 400 and TLE 600 tablets Kumar Jeetendra | May 19, 2020 Laurus Labs Ltd. (Laurus BSE: 540222, NSE: Lauruslabs, ISIN: INE947Q01010) Laurus Labs Ltd is satisfied to declare that the Company has gotten an endorsement 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 …
Avenue Therapeutics gets letter from USFDA for intravenous tramadol Kumar Jeetendra | October 12, 2020 Therapeutics Inc has received a complete response letter (CRL) in the US health regulator for its new drug application for intravenous tramadol. The CRL in the US Food and Drug Administration (USFDA) has said that the regulator has decided it cannot approve the application for IV tramadol in its current form, Avenue Therapeutics said in …
Cipla receives USFDA approval for generic version of Revlimid® (lenalidomide capsules) Kumar Jeetendra | September 7, 2022 Mumbai, India/ New Jersey, United States, September 7, 2022: Cipla Limited (BSE: 500087; NSE: CIPLA EQ) (“Cipla”) announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the United States Food and Drug Administration (US FDA). Cipla’s Lenalidomide …
