USFDA

Global pharma major Lupin Limited announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval and GMP Inspection of its API manufacturing facility located in Visakhapatnam (Vizag), India. The inspection was conducted from March 6 to March 10, 2023 and concluded with no observations.

Marksans Pharma Limited hereby announces that it has received final approval from US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) of Famotidine Tablets USP, 10 mg and 20 mg for over-the-counter (OTC) use.

The product is bioequivalent to the reference listed drug (RLD), Pepcid AC® tablets, a registered trademark of Johnson & Johnson Consumer Inc. which has sales of over $ 200 million in the US market.

Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.

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).