Lupin Limited Receives U.S. FDA Approval

Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.1%.

The product is a generic equivalent of Alphagan P Ophthalmic Solution, 0.1%, of AbbVie Inc. It will be manufactured at Lupin's Pithampur facility in India.

Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Read also: Lupin alliance partner ForDoz gets USFDA nod for Doxorubicin Hydrochloride Liposome Injection

About Open-Angle Glaucoma

Open-Angle Glaucoma is the most common form of glaucoma, a group of eye conditions that damage the optic nerve, leading to vision loss. This damage is often caused by abnormally high pressure in the eye (intraocular pressure), though normal-pressure glaucoma can also occur.

The team had earlier reported that Lupin Limited had received USFDA nod for its Abbreviated New Drug Application for Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Read also: Lupin bags USFDA nod for Travoprost Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution (RLD Alphagan P) had an estimated annual sales of USD 178.5 million in the U.S. (IQVIA MAT June 2024).

About Lupin Limited

Lupin Limited is a global pharmaceutical Company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including:

• Branded and generic formulations
• Complex generics
• Biotechnology products
• Active pharmaceutical ingredients

The company has a presence in India and the U.S. across multiple therapy areas, including:

• Respiratory
• Cardiovascular
• Anti-diabetic
• Anti-infective
• Gastrointestinal
• Central nervous system
• Women’s health

Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.

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