Mylan launches generic Seasonique
PITTSBURGH — Mylan announced on Tuesday that it had launched its generic version of Teva’s Seasonique birth control (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg). The medication saw some $160.7 million in sales in the 12 months that ended on March 31 of this year.
The launch follows the Food and Drug Administration’s approval of Mylan partner Famy Care’s abbreviated new drug application for the drug. Mylan has 271 ANDAs still awaiting FDA approvals, 47 of which are first-to-file opportunities.
FDA approves Aurobindo’s Flagyl generic
BY DSN STAFF
Dayton, N.J. — Aurobindo Pharma Limited has received approval from the Food and Drug Administration for its generic equivalent to Flagyl (metronidazole) tablets in 250- and 500-mg dosage strengths.
The medication is used to treat different types of infections resulting from particular types of bacteria and certain other infectious organisms. It can also be used to prevent infection during an operation.
Teva introduces generic Intuniv
JERUSALEM — The latest addition to Teva’s roster of medication is its generic version of Intuniv (guanfacine) extended release tablets in 1-, 2-, 3- and 4-mg dosage strengths.
Intuniv, which according to March IMS data made $804 million in total sales, is meant to treat attention deficit hyperactivity disorder. The launch of guanfacine brings Teva’s total number of ADHD drugs to eight, and it is the first non-stimulant ADHD drug in its portfolio.
“We recognize the need to make affordable generic treatment options available to patients with ADHD,” Brendan O’Grady, Teva’s President and CEO, North America Generic Medicines, said.
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