News about "United States Food and Drug Administration"

Gland Pharma Receives US FDA Approval for Generic Sugammadex Injection

Gland Pharma has secured US FDA approval for its generic Sugammadex Injection and launched the product in the US, strengthening its injectable portfolio in a market valued at approximately USD 1.6 billion annually.

United States Food And Drug Administration | 29/07/2026 | By News Bureau |  100

Karnataka FDA and US FDA Strengthen Regulatory Partnership to Advance Food and Drug Safety

Karnataka FDA and the US FDA have strengthened their regulatory partnership through a strategic collaboration focused on capacity building, joint training, regulatory innovation and global best practices to enhance food and pharmaceutical quality, manufacturing compliance, and public health standards.

United States Food And Drug Administration | 23/07/2026 | By News Bureau |  107

Lupin Receives Tentative US FDA Nod for Siponimod Tablets, Generic to Novartis' Mayzent

Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Siponimod Tablets in strengths of 0.25 mg, 1 mg and 2 mg.

United States Food And Drug Administration | 05/12/2025 | By Dineshwori |  643

Lupin Gets Approval from US FDA for Prednisolone Acetate Ophthalmic Suspension

Lupin has secured approval from US FDA for its Abbreviated New Drug Application (ANDA) for Prednisolone Acetate Ophthalmic Suspension USP, 1 percent to market a generic equivalent of Pred Forte Ophthalmic Suspension, 1 percent, of AbbVie Inc.

United States Food And Drug Administration | 07/08/2024 | By Aishwarya |  754

Gland Pharma Gets Tentative Approval from USFDA for Latanoprostene Bunod Ophthalmic Solution

Gland Pharma Ltd. has secured tentative approval from the United States Food and Drug Administration (USFDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024 percent.

United States Food And Drug Administration | 24/07/2024 | By Aishwarya |  818

ForDoz Secures US FDA Approval for Doxorubicin Hydrochloride Liposome Injection

Lupin has announced that its alliance partner, ForDoz Pharma Corp. has received approval from US FDA for its Abbreviated New Drug Application for Doxorubicin Hydrochloride Liposome Injection, Single-Dose Vials, to market a generic equivalent of Doxil Liposom.

United States Food And Drug Administration | 22/07/2024 | By Aishwarya |  795

FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors

The U.S. Food and Drug Administration today approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies)

United States Food And Drug Administration | 02/04/2020 | By Darshana |  562

FDA Continues to Accelerate Development of Novel Therapies for COVID-19

As part of the Trump Administration's all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments

United States Food And Drug Administration | 01/04/2020 | By Darshana |  664

Lupin launches Ethacrynic Acid Tablets USP

Pharma major Lupin Limited (Lupin) announced the launch of Ethacrynic Acid Tablets USP, 25 mg, having received approval from the United States Food and Drug Administration (U.S. FDA) earlier. The product would be manufactured at Lupin's Nagpur OSD facility, India

United States Food And Drug Administration | 14/03/2020 | By Darshana |  950