Nov 16, 2015 2 min read

CANONSBURG — Mylan N.V. said Monday it has launched two new generic drugs — one for treatment of HIV and a second for helping to control type 2 diabetes.

The company said in a press release its U.S. launch of 100-milligarm Nevirapine extended-release tablets is the generic version of Boehringer Ingelheim’s Viramune XR.

Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for the product, which is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children age 6 to less than 18 years old.

The launch adds to Mylan’s growing portfolio of ARV medicines across the globe, and represents the company’s continued commitment to stem the tide of HIV/AIDS. According to the company, approximately 50 percent of those being treated for HIV/AIDS in the developing world, for example, rely on a Mylan product.

Nevirapine extended-release tablets, 100 mg, had U.S. sales of approximately $67,000 for the 12 months ending Sept. 30, according to IMS Health.

In a separate release, Mylan also announced the U.S. launch of 5-mg and 10-mg Glipizide extended-release tablets, the generic version of Pfizer’s Glucotrol XL.

Mylan, which received FDA approval for the product, said it is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The drug had U.S. sales of approximately $70.7 million for the 12 months ending Sept.30, according to IMS Health.

IMS also reported that Mylan currently has 253 ANDAs pending FDA approval representing $100.8 billion in annual brand sales. Fifty of the pending ANDAs are potential first-to-file opportunities, representing $36.1 billion in annual brand sales, for the 12 months ending June 30.