Par Launches Generic of Smoking Cessation Drug Chantix

Par Pharmaceutical, part of Endo International, has begun shipping the generic version of Pfizer's Chantix (varenicline), 0.5 mg and 1 mg tablets. Developed by Par Pharmaceutical, which is part of Endo International, the generic varenicline tablet was approved by the FDA August 11, 2021.

This moves comes a week after Pfizer recalled all remaining lots of Chantix due to the presence of a nitrosamine, N-nitroso-varenicline, which may be associated with a potential increased cancer risk in humans.

Dr. Reddy’s launches generic of Librax.

Dr. Reddy’s Laboratories has launched chlordiazepoxide hydrochloride and clidinium bromide

capsules, a generic version of Librax (chlordiazepoxide hydrochloride and clidinium bromide). It is approved to treat gastrointestinal disorders, such as peptic ulcer, irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), and acute enterocolitis. It is available in one strength of 5 mg/2.5 mg capsules in bottle count sizes of 100.

Librax is no longer available on the U.S. market.

FDA approves generic clindamycin phosphate foam.

Glenmark Pharmaceuticals has received FDA approval for clindamycin phosphate foam, 1%, the generic version of Mylan’s Evoclin Foam, 1%, an antibiotic that is used to treat acne.

According to IQVIA sales data for the 12-month period ending July 2021, the Evoclin Foam, 1%, market achieved annual sales of about $12.0 million

FDA approves generic sodium acetate.

The FDA has approved the abbreviated new drug application of Milla Pharmaceuticals’ generic version of sodium acetate injection 2 MEQ/mL as a source of sodium as an addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also used as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

The company, a subsidiary of the Alter Pharma Group, has announced that it has launched this product.

Milla Pharmaceuticals has established its first commercial sale through its exclusive partner, Woodward Pharma Services, and has secured 180-days of market exclusivity. The FDA has recently listed sodium acetate Injection 2MEQ/mL on their its drug shortages list.