News about "United States Food and Drug Administration"

Lupin Gets Approval from US FDA for Prednisolone Acetate Ophthalmic Suspension

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 118

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

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 224

ForDoz Secures US FDA Approval for Doxorubicin Hydrochloride Liposome Injection

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

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

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 247

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

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 430

Lupin launches Ethacrynic Acid Tablets USP

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 564


 

 

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