Generic Products- June 2023

Pharmacy TimesJune 2023
Volume 89
Issue 6

Products treat ulcerative colitis, urinary tract infection, and psoriatic arthritis.

Budesonide 2-mg Rectal Foam

From: Padagis

Compare To: Uceris

Padagis has launched budesonide 2-mg rectal foam for patients with ulcerative colitis. The reference listed drug Uceris (Salix Pharmaceuticals), is a prescription corticosteroid that helps control mild to moderate ulcerative colitis extending from the rectum to the sigmoid colon. It is recommended that the product be applied rectally twice daily for 2 weeks, then once daily for 4 weeks. The most common adverse events include adrenal insufficiency, decreased blood cortisol, and nausea. Investigators do not have efficacy or safety data about the use of the foam in children.

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Nitrofurantoin Oral Suspension USP, 25 mg/5 mL

From: ANI Pharmaceuticals,Inc

Compare To: Furadantin

The FDA has approved an abbreviated new drug application for nitrofurantoin oral suspension USP, 25 mg/5 mL, an antibiotic for the treatment of urinary tract infections (UTIs) and the generic of reference listed drug Furadantin oral suspension 25 mg/5 mL. Nitrofurantoin is indicated for UTIs that are susceptible to strains of Enterococci, Escherichia coli, Staphylococcus aureus, and other species of bacteria. Many patients treated with nitrofurantoin are predisposed to the reappearance of bacteria.

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Tofacitinib Tablets, 5 mg

From: Zydus Lifesciences Ltd

Compare To: Xeljanz

The FDA has granted final approval to Zydus Lifesciences Ltd for its tofacitinib tablets, 5 mg, the generic of Pfizer Inc’s Xeljanz tablets, 5 mg, to treat adults with active psoriatic arthritis and moderately to severely active rheumatoid arthritis. Tofacitinib is also indicated for patients with moderately to severely active ulcerative colitis. The FDA also granted tentative approval to tofacitinib tablets, 10 mg, the generic of Pfizer’s Xeljanz tablets, 10 mg.

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Phenoxybenzamine Hydrochloride Capsules

From: Aurobindo Pharma Limited

Compare To: Dibenzyline

Aurobindo Pharma Unlimited has received permission from the FDA for phenoxybenzamine hydrochloride capsules 10 mg, indicated for the treatment of pheochromocytoma. The drug controls episodes of hypertension and sweating, which are common symptoms of the rare, usually noncancerous tumor. Phenoxybenzamine hydrochloride capsules have a market value of approximately $7.4 million for the 12 months ending in March 2023, according to data from IQVIA.

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