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News Breaks
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November 10, 2009
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| 15:26 EDT |  | MYL |
| theflyonthewall.com: | Mylan receives FDA approval for generic version of Prevacid | | Mylan announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received final approval from the U.S. FDA for its Abbreviated New Drug Application for Lansoprazole Delayed-release Capsules, 15 mg and 30 mg. This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand. Lansoprazole DR Capsules are the generic version of Tap Pharmaceuticals' proton pump inhibitor Prevacid DR Capsules. The brand product had U.S. sales of approximately $3B for the 12 months ending June 30, according to IMS Health. Currently, Mylan has 125 ANDAs pending FDA approval representing $84.1B in annual brand sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.2B in annual brand sales, for the 12 months ending June 30, according to IMS Health. :theflyonthewall.com |
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February 10, 2012
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| 17:19 EDT | | MYL |
| theflyonthewall.com: | Mylan announces unfavorable verdict in patent trial | | Mylan announced that a jury has rendered an unfavorable verdict in a patent infringement lawsuit filed by Sunovion Pharmaceuticals against Mylan, Dey Inc. and Dey Pharma, L.P. in relation to Dey's Abbreviated New Drug Application for Levalbuterol Hydrochloride Inhalation Solution. Levalbuterol HCl is the generic version of Sunovion's Xopenex. The verdict includes an award of $18M. :theflyonthewall.com |
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February 9, 2012
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| 09:09 EDT |  | MYL |
| theflyonthewall.com: | House Energy and Commerce Committee to hold a hearing | | The Health Subcommittee holds a hearing on the new Generic Drug User Fee proposal and Biosimilar User Fee proposal and the ongoing issue of drug shortages. Participates include Director Woodcock of CDER at the FDA, President Bresch of Mylan and Vice President of the Generic Pharmaceutical Association, David Gaugh on February 9 at 10 am. Webcast Link :theflyonthewall.com |
| | 07:38 EDT | | MYL |
| theflyonthewall.com: | Mylan announces final FDA approval of generic Doryx | | Mylan (MYL) announced that it received final approval from the FDA for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-release Tablets USP, 150 mg. This product is the generic version of Mayne Pharma's Doryx, which is marketed by Warner Chilcott (WCRX). The company said the FDA denied Warner Chilcott's Citizen Petition. Mylan agreed that it will not launch its generic Doryx product until after a decision is issued in Warner Chilcott's patent infringement lawsuit against Mylan. This trial is underway in the U.S. District Court for the District of New Jersey and a decision is currently expected in March. :theflyonthewall.com |
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February 6, 2012
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| 08:10 EDT | | MYL |
| theflyonthewall.com: | Valeant Pharma completes divestiture of generic dermatology products to Mylan | | Valeant Pharmaceuticals (VRX) announced that it has completed the divestiture of 1% clindamycin and 5% benzoyl peroxide gel, or IDP-111, a generic version of Benzaclin, and 5% fluorouracil cream, 5-FU, an authorized generic of Efudex, to Mylan (MYL). This action was required under the consent order issued by the Federal Trade Commission, or FTC, as part of the acquisition of Dermik, a dermatology unit of Sanofi (SNY), which was completed in December 2011. :theflyonthewall.com |
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February 2, 2012
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| 07:36 EDT | | MYL |
| theflyonthewall.com: | Mylan receives tentative FDA approval for generic version of Pfizer's Lipitor |
 Subscribe for More Information :theflyonthewall.com |
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February 1, 2012
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| 11:00 EDT |  | MYL |
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