Generic Products- June 2023
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.
For More Information:
padagis.com
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.
For More Information:
anipharmaceuticals.com
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.
For More Information:
zyduslife.com
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.
For More Information:
aurobindo.com
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