Mylan N.V. has launch Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical’s AXERT in the U.S.
In an announcement on Tuesday, Mylan said it had 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 for the acute treatment of migraine attacks in adult patients with a history of migraine with or without aura.
Mylan explained that in adolescents age 12 to 17 years, it is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).
The company added that Almotriptan Tablets USP, 6.25 mg and 12.5 mg, had U.S. sales of approximately $29.2 million for the 12 months ending Sept. 30, 2015, according to IMS Health.
“Currently, Mylan has 253 ANDAs pending FDA approval representing $100.8 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $36.1 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health,” the company said in its press release.
$1 Billion Share Repurchase Plan
In a separate announcement, on Monday, the Mylan said it has authorized share repurchases by the Company of its ordinary shares in an amount up to $1 billion, either in the open market through privately-negotiated transactions or in one or more self tender offers.
The repurchase program does not obligate the Company to acquire any particular amount of ordinary shares. The authorization expires on Aug. 27, 2016.
Mylan’s Executive Chairman Robert J. Coury said that the company remained focused on utilizing the optionality provided by its strong balance sheet and ample financial flexibility in pursuit of external opportunities that further build on the company’s existing platform. He said that it will position Mylan for continued growth and value creation.
“We have already identified a number of potential opportunities. That said, the Board’s authorization of an up to $1 billion share repurchase provides us with optimal flexibility and allows us to be opportunistic in repurchasing shares, thereby investing in Mylan’s strong growth prospects and exciting future, which we continue to believe are substantially undervalued,” Coury concluded.