Generic Product News: April 2023

Febuxostat Tablets, 40 mg, 80 mg

From: Zydus Lifesciences

Compare To: Uloric

The FDA approved febuxostat tablets in the 40- and 80-mg dosage amounts to treat patients with lower hyperuricemia, or high uric acid in the blood.The drug is indicated for patients with gout, a form of arthritis caused by uric buildup in the joints.Febuxostat is for patients who cannot use allopurinol or who were unsuccessfully treated with allopurinol, a treatment that lowers high uric acid levels in the blood.The most common adverse events (AEs) include joint pain and nausea, with more serious AEs including rash, skin redness, skin peeling, and swelling of the lips, mouth, throat and/or tongue.The market for febuxostat tablets in the United States is estimated at $32 million in annual sales, according to IQVIA.

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zyduslife.com

Glycopyrrolate Injection

From: Lupin

Compare To: Robinul Injection

The FDA approved glycopyrrolate injection, a generic form of Robinul Injection from Hikma Pharmaceuticals. Glycopyrrolate injection is indicated for use before surgery, effectively decreasing the volume of secretions made by the lungs, mouth, and stomach. The approval allows Lupin to fast-track its injectable portfolio rollout, according to the company. IQVIA data suggest that glycopyrrolate injection single-dose vials in dosages of 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) and multiple-dose vials in dosages of 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) have estimated revenue of $39 million.

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lupin.com

Canagliflozin Tablets, 100 mg and 300 mg

From: Zydus Lifesciences

Compare To: Invokana Tablets

The FDA granted tentative approval to canagliflozin tablets in the 100- and 300-mg strengths. Canagliflozin tablets are sodium-glucose cotransporter-2 inhibitors for patients with type 2 diabetes who want to improve glycemic control. Canagliflozin tablets are indicated as an adjunct treatment to diet and exercise treatments. December 2022 IQVIA data show that annual sales for canagliflozin tablets were $660 million in the United States.

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zyduslife.com

Bosentan Tablets for Oral Suspension, 32 mg

From: Zydus Lifesciences

Compare To: Tracleer Tablets for Oral Suspension

The FDA granted tentative approval to Zydus Lifesciences’ bosentan tablets for oral suspension 32 mg , indicated to treat pulmonary arterial hypertension (PAH) in individuals 3 years and older. The drug works by improving pulmonary vascular resistance in patients with congenital or idiopathic PAH. Estimates show that bosentan tablets for oral suspension had annual sales of $16 million in the United States in 2022, according to IQVIA data for December 2022.

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