Mylan N.V. today announced the U.S. launch of Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, a generic version of Pfizer’s Pristiq Tablets. 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 indicated for the treatment of major depressive disorder1.
Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, had U.S. sales of approximately $853 million for the 12 months ending January 31, 2017, according to IMS Health.
Currently, Mylan has 241 ANDAs pending FDA approval representing approximately $100.9 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $39 billion in annual brand sales, for the 12 months ending December 31, 2016, according to IMS Health.
Mylan, a producer of active pharmaceutical ingredients, maintains a portfolio of approximately 7,500 marketed products in more than 165 countries and territories.
1 Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents and young adults. Monitor for worsening and emergence of suicidal thoughts and behaviors. This medicine is not approved for use in pediatric patients.
(Source: PR Newswire)
Filed Under: Drug Discovery