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Lupin receives FDA nod for 2 generics, launches generic Nascobal

Lupin obtained approval for generic BromSite and generic Multaq and launched generic Nascobal.
Sandra Levy
Senior Editor
Levy

Lupin has obtained the Food and Drug Administration’s permission for two new generics and the company has launched an additional generic.

The FDA approved Bromfenac Ophthalmic Solution, 0.075%, which is the generic of Sun Pharmaceutical’s BromSite. 

Lupin is the exclusive first-to-file for this product, and it will be manufactured at its Pithampur facility in India.

Bromfenac Ophthalmic Solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

[Read more: Lupin receives FDA OK for generic Banzel]

Bromfenac Ophthalmic Solution had a market value of roughly $15 million, per IQVIA December 2023 data.

Lupin also received the green light for Dronedarone Tablets, 400 mg, which is the generic of Sanofi-Aventis U.S.’s Multaq. 

The product, to be manufactured at the company’s Goa facility in India, is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent AF.

Dronedarone Tablets had a market value of approximately $510 million, per IQVIA December 2023 data.

Lupin also launched a new generic—Cyanocobalamin Nasal Spray, 500 mcg/spray (One Spray per Device). The product is a generic equivalent of Par’s Nascobal. 

[Read more: Lupin receives FDA OK for generic Uloric]

It is indicated for vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement. 

As well as the treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia; and the prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements more than normal.

Cyanocobalamin Nasal Spray had a market value of roughly $59 million, per IQVIA December 2023 data.

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