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Mylan Pharmaceuticals receives FDA approval for a generic drug

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Yesterday Mylan Pharmaceuticals Inc. in Canonsburg, Pennsylvania announced the receipt of final approval from the U.S. Food and Drug Administration (FDA) for the launch for its Abbreviated New Drug Application (ANDA) of a generic drug which can be used to treat overactive bladder. The generic drug is Tolterodine Tartrate Extended-release (ER) Capsules, 2 mg and 4 mg, which is a generic version of Pfizer's Detrol® LA (treats symptoms of urge urinary incontinence, urgency and frequency). IMS Health reports almost $571.5 in U.S. sales for 2013. IMS Health is a company that provides information, services and technology for the healthcare industry. It is the largest vendor of U.S. physician prescribing data.

“Tolterodine Tartrate ER Capsules had U.S. sales of approximately $571.5 million for the 12 months ending Sept. 30, 2013, according to IMS Health. Currently, Mylan has 188 ANDAs pending FDA approval representing $94 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDAapproval.”

As a generics and specialty pharmaceutical company, Mylan Inc. is a global industry leader. It is fully integrated to develop, license, manufacture, market and distribute generic, branded generic and specialty pharmaceuticals. Mylan has a U.S. subsidiary Mylan Pharmaceuticals Inc. in Canonsburg, PA and a subsidiary in India Mylan Laboratories Limited. Mylan was founded in West Virginia in 1961 and received their first FDA approval with the medicine Penicillin G. The company logo is the letter M derived from three test tubes.

Mylan Inc. (NASDAQ:MYL) is traded in the healthcare sector of the pharmaceuticals industry on the NADAQ. It closed the trading day yesterday with an average closing price of 42.98. The average closing price for 2013 was 33.88. The first through fourth quarter average closing prices were 29.06, 29.87, 35.20 and 41.10 respectively.

New developments have started for the year 2014 to impact the healthcare and services industries. The first nationalized U.S. Healthcare system starts in the U.S., and drones are being tested for use in pharmaceutical delivery in Germany by Deutsche Post and merchandise delivery by Amazon in the U.S.

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