Generic Product News - October 2021

Pharmacy Times, October 2021, Volume 87, Issue 10

Ibuprofen and Famotidine Tablets

Marketed by Alkem Laboratories

Compare To: Duexis tablets
Alkem Laboratories’ generic ibuprofen and famotidine tablet in a strength of 800 mg/26.6 mg represents the first FDA approval of generic Duexis tablets. The drug is indicated to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis and to lower the risk of developing upper gastrointestinal ulcers. In clinical trials, these ulcers were defined as a duodenal and/or gastric ulcer in patients taking ibuprofen for those indications. The launch of the drug is the subject of continuing litigation.

Norethindrone Acetate and Ethinyl Estradiol Capsules, Ferrous Fumarate Capsules (Taysofy)

Marketed by Amneal Pharmaceuticals

Compare to: Taytulla
Amneal Pharmaceuticals has launched norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules 1 mg/20 g, indicated as a low-dose contraceptive. In addition to preventing pregnancy, the established 24/4 regimen can also cause light, short periods. The medication is contraindicated in patients with a high risk of arterial or venous thrombotic diseases, liver disease or tumors, undiagnosed abnormal uterine bleeding, and those who have received a diagnosis of breast cancer or other estrogen- or progestin-sensitive cancers. In clinical trials, the most common adverse reactions were abnormal cervical smear, acne, bacterial vaginosis, breast tenderness, headache, menstrual cramps, mood swings, nausea, vaginal candidiasis, and weight gain.

Apixaban Tablets

Marketed by Breckenridge Pharmaceuticals

Compare to: Eliquis
Breckenridge Pharmaceuticals is launching generic apixaban tablets, indicated to reduce the risk of blood clots and strokes in individuals who have atrial fibrillation not caused by a heart valve problem. Warnings for the drug include epidural or spinal hematoma and an increased risk of thrombotic events in individuals who discontinue treatment prematurely. The most common and most serious adverse reactions reported in clinical trials were related to bleeding. Eliquis had a market value of $14 billion during the 12 months ended in May 2021, according to industry data from IQVIA.

Naloxone HCL Nasal Spray (Kloxxado)

Marketed by Hikma Pharmaceuticals

Compare to: Narcan
Hikma Pharmaceuticals is launching its generic naloxone HCL nasal spray in a strength of 8 mg, following FDA approval in April for the emergency treatment of known or suspected opioid overdose as manifested by central nervous system and/or respiratory depression, for both adult and pediatric patients. The generic contains twice as much naloxone per spray as Narcan Nasal Spray 4 mg in a ready-to-use nasal spray and offers a vital new treatment option to address the opioid epidemic, according to the company.