Generic products featured in the September 2020 issue of Pharmacy Times.
DOXYCYCLINE HYCLATE TABLETS
MARKETED BY: Alembic
COMPARE TO: Almirall
Indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of other antibacterial drugs, Alembic’s new generic doxycycline hyclate tablets are available in 60-count bottles and strengths of 75 mg and 150 mg. Common adverse effects may include diarrhea, nausea, or vomiting, and prolonged or repeated use may result in oral thrush or vaginal yeast infection. Doxycycline hyclate tablets, 75 mg and 150 mg, had an estimated market size of $17 million for the 12 months ending in March 2020, according to a company statement.
FOR MORE INFORMATION: alembicpharmaceuticals.com
FLUPHENAZINE HYDROCHLORIDE TABLETSMARKETED BY: Amneal Pharmaceuticals
COMPARE TO: Prolixin
Following FDA approval, Amneal’s generic fluphenazine hydrochloridetablets offer a new treatment option for patients with schizophrenia. Available in dosage strengths of 1, 2.5, 5, and 10 mg, the drug functions by balancing neurotransmitters in the brain. Effective treatment with fluphenazine can reduce episodes of bizarre behavior, delusions, and hallucinations common in patients with schizophrenia. It is not approvedfor patients under 12 years of age and should not be used to manage behavioral problems in patients with mental illnesses other than schizophrenia.
FOR MORE INFORMATION: amneal.com
MARKETED BY: Teva
COMPARE TO: Gilenya
Indicated for the treatment of relapsing-remitting multiple sclerosis, fingolimod hydrochloride is a sphingosine 1—phosphate receptor modulator originally approved by the
FDA in 2010; the new generic approval offers more options for this patient population. Fingolimod hydrochloride has shown efficacy in adult and pediatric populations, and although clinical trials have established a reliable safety and tolerability profile, adverse effects can include bradycardia, headache or migraine, gastrointestinal problems, and a higher risk of infection. Notably, the drug is also being investigated for use in patients with coronavirus disease 2019, with at least 1 clinical trial under way.
FOR MORE INFORMATION: tevapharm.com
MARKETED BY: Alkem Laboratories
COMPARE TO: Samsca
Tolvaptan tablets in dosage strengths of15, 30, and 60 mg recently received a tentative approval for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. The drug should be initiated and reinitiated in a hospital environment where serum sodium can be closely monitored due to the risks of rapidly correcting hyponatremia. The most common adverse effects observed in 2 clinical trials included asthenia, constipation, dry mouth, hyperglycemia, and thirst.
FOR MORE INFORMATION: alkemlabs.com