VESIcare comprises solifenacin succinate, a muscarinic antagonist that is indicated to treat patients suffering from urge incontinence by decreasing urinary frequency.
Statistics from IQVIA show that the non-generic variant of VESIcare tablets generated more than $955m in annual sales in the US, as of February this year.
Teva Pharmaceutical North America Commercial executive vice-president and head Brendan O’Grady said: “About 33 million Americans have overactive bladder. We’re proud to offer another treatment option for this common condition.”
The company’s portfolio includes around 500 generic medicines. The US Food and Drug Administration (FDA) recently granted final approval for Teva’s generic naloxone hydrochloride nasal spray Narcan to treat opioid overdose. While generic injectable naloxone products are available in the market, this is one of the first generic naloxone nasal sprays for use in a community setting by individuals without medical training.
The FDA provided tentative approval for the generic nasal spray in June last year. The latest authorisation allows marketing of the product, which is available for both adults and children.
However, the FDA said that use of the nasal spray in opioid-dependent patients could lead to severe opioid withdrawal symptoms such as body aches, diarrhoea, increased heart rate, fever, nausea and vomiting, as well as weakness and increased blood pressure.
The FDA Center for Drug Evaluation and Research regulatory programmes deputy centre director Douglas Throckmorton said: “In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritise our review of generic drug applications for naloxone.”
The Centers for Disease Control and Prevention data reveals that more than 130 people in the US die each day due to opioid overdoses.
Quick administration of naloxone nasal spray is expected to counter the overdose effects within minutes. Patients will also require further immediate medical attention.