Mylan launches three different tablets in US in two days

Mylan launches three different tablets in US in two days

December 30, 2016 Off By Dino Mustafić

Mylan has had a rather busy week, as it got approvals for three of its generic medicines in last three days. It announced launching three generics into the multi-billion U.S. worth market on Wednesday and Thursday.

The U.S. Food and Drug Administration (FDA) has given approval to Mylan to launch a generic version of Janssen’s tablets Concerta, for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). These tablets, of certain dosage, had U.S. sales of approximately $1.59 billion for the 12 months ending October 31, 2016, according to IMS Health.

Mylan has also gotten the approval for a generic version of Pfizer’s Cerebyx Injection for the treatment of certain types of severe seizures. It had had U.S. sales of approximately $36.3 million in 2016, 12 months until October.

Furthermore, Mylan’s subsidiary, Jai Pharma Limited, received approval from the FDA for its Abbreviated New Drug Application (ANDA) for birth control tablets, equivalent to the reference listed drug, Zovia, which is indicated for use by women to prevent pregnancy.

Currently, Mylan has more than 240 ANDAs pending FDA approval representing approximately $95.6 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $32.5 billion in annual brand sales, for the 12 months ending June 30, 2016, according to IMS Health.

Commenting on the launch of Concerta ADHD generic tablets, the Mylan CEO  Heather Bresch said that the launch reaffirms the company’s focus on drugs to treat central nervous system, which in the U.S. has more than 100 products.

“We’re excited about bringing another generic in this therapeutic area to market and expanding access to help patients,” Bresch said.