September 2021 Generic Product News

Pharmacy Times, September 2021 , Volume 87, Issue 9

This month's featured products include desipramine hydrochloride tablets, fingolimod capsules, and more.

Desipramine Hydrochloride Tablets

Marketed by: Alembic Pharmaceuticals

Compare to: Norpramin

One of 2 recently approved generics from Alembic Pharmaceuticals, desipramine hydrochloride tablets have been approved in strengths of 10, 25, 50, 75, 100, and 150 mg. The tablets are used to treat depression and may improve appetite, energy levels, mood, and sleep by balancing norepinephrine levels in the brain. Common adverse effects include blurred vision, constipation, dizziness, drowsiness, dry mouth, headache, increased appetite, nausea, nervousness, trouble sleeping, and weight gain. The tablets are not recommended for children younger than 18 years because of the risk of serious adverse effects.

For more information: alembicpharmaceuticals.com

Fingolimod Capsules

Marketed by: Zydus Cadila

Compare to: Gilenya

The FDA has granted tentative approval to a new strength of Zydus Cadila’s generic fingolimod capsules, now in a 0.25-mg strength. The capsules are an immunomodulating drug and a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients 10 years and older with relapsing forms of multiple sclerosis, including those with active secondary progressive disease, clinically isolated syndrome, and relapsing-remitting disease. Adverse effects can include abdominal and back pain, diarrhea, hair loss, headache, nausea, and weakness. Zydus Cadila received approval for fingolimod capsules in a 0.5-mg strength in October 2020.

For more information: zyduscadila.com

Nitrofurantoin Capsules

Marketed by: Alembic Pharmaceuticals

Compare to: Macrodantin

The FDA has approved Alembic’s nitrofurantoin (macrocrystals) capsules in strengths of 25, 50, and 100 mg. The drug is indicated for the treatment of urinary tract infections due to susceptible strains of Enterococcus, Escherichia coli, Staphylococcus aureus, and certain susceptible strains of the Enterobacter and Klebsiella species. Common adverse effects can include headache, loss of appetite, nausea, and vomiting. Nitrofurantoin is not recommended for children younger than 1 month because of the risk of hemolytic anemia.

For more information: alembicpharmaceuticals.com

Fluvastatin Sodium Extended-Release Tablets

Marketed by: Lannett

Compare to: Lescol XL Tablets

Lannett is introducing fluvastatin sodium extended-release tablets in a strength of 80 mg, indicated as an adjunct to diet to treat elevated cholesterol levels. Patients with heart disease may use them to lower the risk of heart problems and slow the buildup of cholesterol in the arteries. Serious adverse reactions can include acute renal failure and myopathy, liver enzyme abnormalities, and rhabdomyolysis with myoglobinuria. The tablets had a market value of approximately $10 million for the 12 months ended May 2021, though actual generic market values are expected to be lower.

For more information: lannett.com