Mylan N.V. announced the U.S. launch of Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg, and 16 mg, a generic version of the reference listed drug, Trilafon Tablets 2 mg, 4 mg, 8 mg, and 16 mg, originally marketed by Schering.
Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults1.
Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg, and 16 mg, had U.S. sales of approximately $41 million for the 12 months ending Feb. 28, 2017, according to IMS Health.
Currently, Mylan has 236 ANDAs pending FDA approval representing approximately $104.3 billion in annual brand sales, according to IMS Health. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $42.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2016, according to IMS Health.
Mylan offers a growing portfolio of approximately 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50 percent of people being treated for HIV/AIDS in the developing world depend. Products are marketed in more than 165 countries and territories. Mylan also produces active pharmaceutical ingredients. mylan.com.
1 Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials. The deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g. pneumonia) in nature. This drug is not approved for the treatment of patients with dementia-related psychosis.
(Source: PR Newswire)
Filed Under: Drug Discovery