Mylan Launches Generic Concerta and Zovia in the US Market
Mylan launched 2 generic pharmaceutical products at the end of December for the treatment of attention deficit hyperactivity disorder (ADHD) and the prevention of pregnancy.
On December 28, Mylan launched a generic version of Zovia, also known as ethynodiol diacetate and ethinyl estradiol. The tablets are designed specifically for women who want to prevent pregnancy. Mylan’s subsidiary, Jai Pharma Limited, received final approval from the FDA for the abbreviated new drug application (ANDA) for the product.
The most common adverse effects associated with Zovia are light vaginal bleeding or spotting, nausea, vomiting, and bloating.
The next day, the company launched a generic version of Janssen's Concerta, also known as methylphenidate hydrochloride, in the US market. It received final FDA approval for the product’s ANDA. The most common adverse reactions associated with Concerta are decreased appetite, headache, dry mouth, and nausea.
"The launch of generic Concerta tablets demonstrates Mylan's leadership in complex development and manufacturing and in bringing to market a broad portfolio of high quality generics,” Mylan CEO, Heather Bresch, said in a press release. “This launch also further strengthens our robust portfolio of central nervous system medications, which is the largest in the United States with more than 100 products. We're excited about bringing another generic in this therapeutic area to market and expanding access to help patients."