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Lupin receives FDA nod for 3 generics

The FDA has approved Lupin's generic Alrex, generic Zyloprim and generic Januvia.
Levy

Lupin recently received the Food and Drug Administration’s blessing for three generics.

Lupin has received permission from the FDA for Loteprednol Etabonate Ophthalmic Suspension, 0.2%, which is the generic of Bausch & Lomb’s Alrex. 

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Loteprednol Etabonate Ophthalmic Suspension, 0.2% (RLD Alrex), had a market value of roughly $29.1 million, per IQVIA October 2023 data.

Lupin also has obtained the FDA’s clearance for Allopurinol Tablets, 100 mg and 300 mg, which is the generic of Casper Pharma’s Zyloprim. 

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

Allopurinol Tablets are indicated for the management of:

  • Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy);
  • Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels; and
  • Adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes. 

Allopurinol Tablets (RLD Zyloprim) had a market value of roughly $88.1 million, per IQVIA October 2023 data.

Lupin also has received the FDA’s green light for Sitagliptin Tablets, 25 mg, 50 mg, and 100 mg, which is a generic of Merck’s Januvia. 

Sitagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes mellitus.

Sitagliptin Tablets (RLD Januvia) had a market value of approximately $5.8 billion, per IQVIA October 2023 data.

The three new generics will be manufactured at Lupin’s Pithampur facility in India.

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