BioCentury | Feb 6, 2012
Clinical News

Dulera mometasone/Formoterol regulatory update

...its 4Q11 earnings that FDA issued a complete response letter for an sNDA for Dulera mometasone/formoterol...
...in the U.S. for asthma. Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Dulera mometasone/Formoterol...
BioCentury | Feb 3, 2012
Company News

Merck reports financial results, regulatory updates

...metformin. Merck also said FDA issued a complete response letter for an sNDA for Dulera mometasone/formoterol...
...The pharma said it is discussing the letter with FDA, but did not disclose details. Dulera...
BioCentury | Jan 9, 2012
Finance

PDUFAs produce yawns

...Promacta - U.S.) Chronic idiopathic thrombocytopenic purpura (ITP) EU Merck & Co. Inc. (NYSE:MRK) Dulera mometasone/formoterol...
BioCentury | Nov 21, 2011
Clinical News

Dulera mometasone/Formoterol: Phase III data

...first co-primary endpoint, twice-daily low- and high-dose Dulera (200 µg/10 µg and 400 µg/10 µg mometasone/formoterol...
...26 by 77 and 3 mL, respectively. On the second co-primary endpoint, low- and high-dose Dulera...
...with an undisclosed PDUFA date. Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Dulera mometasone/Formoterol...
BioCentury | Nov 21, 2011
Clinical News

Dulera mometasone/Formoterol: Phase III data

...A double-blind, placebo-controlled Phase III trial in 1,196 patients showed that both doses of Dulera met...
...first co-primary endpoint, twice-daily low- and high-dose Dulera (200 µg/10 µg and 400 µg/10 µg mometasone/formoterol...
...with an undisclosed PDUFA date. Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Dulera mometasone/Formoterol...
BioCentury | Aug 1, 2011
Clinical News

Dulera mometasone/formoterol regulatory update

...FDA accepted for review an sNDA for Dulera mometasone/formoterol to treat chronic obstructive pulmonary disease (COPD...
...is already approved for asthma. Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Dulera mometasone/formoterol...
BioCentury | Jul 29, 2011
Company News

Merck provides pipeline update

...were not disclosed. On the regulatory front, FDA accepted for review an sNDA for Dulera mometasone/formoterol...
BioCentury | Jul 4, 2011
Finance

3Q Financial Markets Preview: Flavored with Phase III

...Inc. (NASDAQ:ISIS)/ Sanofi (Euronext:SAN; NYSE:SNY) Mipomersen hoFH Submit MAA 3Q11 Merck & Co. Inc. (NYSE:MRK) Dulera...
BioCentury | Apr 18, 2011
Clinical News

Advair salmeterol/fluticasone: Postmarketing study start

...marketed LABAs when added to corticosteroids (see BioCentury, March 15, 2010). Product: Advair salmeterol/fluticasone; Dulera mometasone/formoterol...
...LABAs: Foradil formoterol from Novartis; Symbicort formoterol/budesonide from AstraZeneca; Advair salmeterol/fluticasone from GlaxoSmithKline; and Dulera mometasone/formoterol...
BioCentury | Apr 16, 2011
Company News

FDA requiring LABA safety trials

...formoterol/budesonide from AstraZeneca plc (LSE:AZN; NYSE:AZN); Advair salmeterol/fluticasone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK); and Dulera mometasone/formoterol...
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