USFDA

Alembic Pharmaceuticals Limited announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Apixaban Tablets, 2.5 mg and 5 mg (USRLD: Eliquis® Tablets).

Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg.

It is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC. Granules now has a total of 54 ANDA approvals from US FDA (52 Final approvals and 2 tentative approvals).

Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets. This product would be manufactured at Lupin’s Nagpur facility in India.

DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- & middle-income countries.

Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly-owned foreign subsidiary of the company, for Amphetamine Mixed Salts, 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) capsules. It is bioequivalent to the reference listed drug product (RLD), Adderall XR® Extended-Release capsules of Takeda Pharmaceuticals USA Inc.

Zydus Lifesciences Limited’s subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus) has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, and 120 mg (USRLD: Fetzima® Extended-Release Capsules).

Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, to market a generic equivalent of Juluca® Tablets, 50 mg/25 mg of ViiV Healthcare Company.

Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, to market a generic equivalent of Toviaz® Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. The product will be manufactured at Lupin’s facility in Goa, India.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Triazolam Tablets USP, 0.125 mg and 0.25 mg.

Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep). It works by slowing activity in the brain to allow sleep. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.