August 2021 Generic Product News
This month's featured products include lopinavir and ritonavir tablets, osimertinib tablets, and more.
Fluticasone Propionate and Salmeterol Inhalation Powder
Marketed by Lannett Company, Inc
Compare to: Advair Diskus
The FDA has accepted Lannett's abbreviated new drug application for fluticasone propionate and salmeterol inhalation powder in 3 strengths. If approved, the product would be the generic equivalent of GlaxoSmithKline's Avair Diskus, which is indicated as a maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease and as a twice-daily treatment for asthma in patients 4 years and older. Lannett has entered into an exclusive 12-year US distribution agreement for this generic product, enabling the company to commence US distribution after FDA approval.
For more information: lannett.com
Lopinavir and Ritonavir Tablets
Manufactured by Camber Pharmaceuticals
Compare to: Kaletra
Camber has launched lopinavir and ritonavir tablets in 100-mg/25-mg, 60-count bottles and 200-mg/50-mg, 120-count bottles. The drug is indicated in combination with other HIV medications to control infection, prolong life, and slow disease progress. The once-daily dosing is available for both treated and treatment naive and has been shown to be as effective as twice-daily dosing in patients treated with antiviral medications. Serious adverse effects can include changes to the heart rhythm and electrical activity of the heart, interactions with other medications, liver problems, and pancreatitis.
For more information: camberpharma.com
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
Manufactured by Lupin Limited
Compare to: Truvada
The FDA has approved Lupin's abbreviated new drug application for emtricitabine and tenofovir disoproxil fumarate tablets in a dosage strength of 200 mg/300 mg. The medication is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection and for preexposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection. Common adverse effects can include depression, diarrhea, dizziness, nausea, stomach pain, and vomiting.
For more information: lupin.com
Manufactured by Zydus Cadila
Compare to: Tagrisso
Zydus Cadila has received tentative FDA approval to market osimertinib tablets in dosage strengths of 40 mg and 80 mg. The product is indicated to treat lung cancer and is a kinase inhibitor. It works by slowing or stopping the growth of cancer cells by binding to specific mutated forms of the EGFR protein in some tumors. Serious adverse effects can include eye problems, heart problems including heart failure, inflammation of blood vessels in the skin, lung problems, and skin problems.
For more information: zyduscadila.com