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475 News Found

Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable
News | September 14, 2024

Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable

Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market


Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg
Drug Approval | September 06, 2024

Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug


Lupin launches Mirabegron ER tablets in US
Drug Approval | September 04, 2024

Lupin launches Mirabegron ER tablets in US

Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development


Lupin launches Doxorubicin Hydrochloride Liposome Injection in US
Drug Approval | September 03, 2024

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US

ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA


Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%
Drug Approval | August 28, 2024

Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%

Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg
Drug Approval | August 21, 2024

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India


Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution
Drug Approval | August 17, 2024

Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.


Zydus receives final approval from USFDA for Valbenazine Capsules
Drug Approval | August 11, 2024

Zydus receives final approval from USFDA for Valbenazine Capsules

Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)


Granules India receives ANDA approval for Trazodone Tablets
Drug Approval | August 11, 2024

Granules India receives ANDA approval for Trazodone Tablets

Trazodone tablets are indicated for the treatment of major depressive disorder in adults