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 …
Unichem Laboratories gets USFDA gesture for Cyclobenzaprine HCI Tablets Kumar Jeetendra | July 8, 2020 Unichem Laboratories has gotten ANDA endorsement for its Cyclobenzaprine Hydrochloride Tablets USP, 5 mg, 7.5 mg and 10 mg from the United States Food and Drug Administration (USFDA) to showcase a nonexclusive rendition of FLEXERIL (Cyclobenzaprine HCI) Tablets, 5 mg and 10 mg of Janssen Research and Development LLC. Cyclobenzaprine HCI Tablets are shown for …
Zydus Cadila gets speculative USFDA gesture for generic drug Kumar Jeetendra | October 19, 2020 New Delhi, Oct 19 Drug firm Zydus Cadila on Monday said it has received tentative approval from the US health regulator to advertise Tofacitinib extended-release pills, used to treat ulcerative colitis, in the American market. The company has received tentative approval from the US Food and Drug Administration (USFDA) for the item which is the …
Strides Pharma gets USFDA endorsement for Prednisone tablets Kumar Jeetendra | February 13, 2021 New Delhi: Drug company Strides Pharma Science on Friday said its subsidiary, Strides Pharma International Pte Ltd, has received approval from the US health regulator for Prednisone pills , prescribed for a variety of conditions, such as allergies, respiratory disease and arthritis. Strides Pharma Global Pte Limited, Singapore, has obtained approval for Prednisone tablets USP …
Alembic Pharma gets USFDA gesture for bipolar depression drug Kumar Jeetendra | May 15, 2021 New Delhi, May 14 (PTI) Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Lurasidone Hydrochloride tablets, used to treat bipolar depression. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc. The company has received approval …
