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Latest Celecoxib Stories

2014-06-02 08:29:10

Mylan will launch all strengths at earliest market formation PITTSBURGH, June 2, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has entered into a settlement and license agreement with Pfizer Inc. relating to Mylan's Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA) for Celecoxib Capsules, 50 mg, 100 mg, 200 mg and 400 mg. This product is the generic version of Celebrex(®), which is indicated for the relief of the...

2014-05-30 12:26:11

Expects to Imminently Receive Final Approval on 50 mg Strength; Has Received Tentative Approval on All Strengths PITTSBURGH, May 30, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today commented on the decision by the United States District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the U.S. Food and Drug Administration (FDA), challenging the agency's decision regarding generic drug marketing exclusivity on Celecoxib...

2014-04-28 16:31:49

DUBLIN, April 28, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that its subsidiary, Watson Laboratories, Inc., has filed suit against the U.S. Food and Drug Administration (FDA) challenging the Agency's decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex(®) (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules. Actavis maintains that the FDA improperly awarded sole exclusivity on generic Celebrex(®) to...

2014-04-25 20:21:31

Mylan Seeks to Confirm Shared 180-Day Exclusivity PITTSBURGH, April 25, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has filed suit against the U.S. Food and Drug Administration (FDA), challenging the agency's decision regarding generic drug marketing exclusivity on Celecoxib Capsules, the generic version of Pfizer's Celebrex(®). FDA issued a decision holding that eligibility for 180 days of exclusivity is only available to an applicant who first filed a...

2014-04-24 10:48:03

The humble aspirin may have just added another beneficial effect beyond its ability to ameliorate headaches and reduce the risk of heart attacks: lowering colon cancer risk among people with high levels of a specific type of gene. The extraordinary finding comes from a multi-institutional team that analyzed data and other material from two long-term studies involving nearly 128,000 participants. The researchers found that individuals whose colons have high levels of a specific gene product...

2014-04-24 08:36:01

DUBLIN, April 24, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has entered into an agreement with Pfizer, Inc. to settle all outstanding patent litigation related to Actavis' generic version of Celebrex(® )(celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules. Celebrex(®) is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Under the terms...

2014-03-13 08:28:09

PITTSBURGH, March 13, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that the United States District Court for the Eastern District of Virginia has ruled invalid a patent, United States Patent No. RE44,048, related to Pfizer's Celebrex® (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules. Mylan was sued by G.D. Searle LLC and Pfizer Asia Pacific PTE, Ltd. for alleged infringement of this patent in connection with Mylan's Abbreviated New Drug Application (ANDA) for...

2014-03-12 20:24:16

DUBLIN, March 12, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the United States District Court for the Eastern District of Virginia has ruled that United States Patent No. RE44,048 (the '048 Patent) is invalid. Actavis was earlier sued by Plaintiffs G.D. Searle LLC and Pfizer Asia Pacific PTE, Ltd. for infringement of the '048 Patent in connection with its Abbreviated New Drug Application directed to Actavis' generic version of Pfizer's Celebrex® (celecoxib)...

2014-02-10 08:26:43

MISSISSAUGA, ON, Feb. 10, 2014 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products today announced the U.S. commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) by its U.S. commercial licensee Mallinckrodt (NYSE:MNK). PENNSAID 2% is the first twice per day topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the United States for the...

2014-01-17 08:22:56

- Mallinckrodt to Launch PENNSAID 2% in the U.S. in Q1 2014 - MISSISSAUGA, ON, Jan. 17, 2014 /PRNewswire/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of products in the areas of topical pain and immunology today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's New Drug Application for PENNSAID(®) (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a follow-on product to...


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