Category FDA Final Approvals

JCI Pharmaceutical Co., Ltd. Receives Approval from US FDA for Colloidal Iodine Formulation

Nov20

Tokyo, Nov 20, 2014 – (ACN Newswire) – JCI Pharmaceutical Co., Ltd. has announced approval by the US FDA for its MN colloid iodine (C.I.M.N), a formulation utilizing a world-first technology for converting iodine into a colloidal state to make it absorbable into the body at a large doses. The new formulation converts iodine[1] into […]

RANBAXY SUES USFDA FOR REVOKING DRUG APPROVALS

Nov19

Ranbaxy Laboratories Ltd has sued the US Food and Drug Administration (FDA) for revoking the tentative approvals of Nexium and Valcyte. The FDA has also withdrawn six-month market exclusivity of Valcyte. The USFDA had banned export of drugs manufactured at the plants of Ranbaxy in India to the US. Ranbaxy had paid fines of $500 […]

Ranbaxy sues FDA for revoking approvals [DNA : Daily News & Analysis (India)]

Nov19

Mumbai: Ranbaxy Laboratories, the company in waiting to be merged with Sun Pharma, has taken a legal recourse against the US drug regulator for revoking the tentative approvals granted for launching the generic versions of AstraZeneca’s heartburn drug Nexium and Roche’s antiviral Valcyte in the US.According to analysts, Ranbaxy could have gained $250 million had […]

Ranbaxy sues US drug regulator for revoking approvals [India Business] [Times of India]

Nov19

NEW DELHI: Drug maker Ranbaxy Laboratories, which is yet to resolve its long pending issues with the US drug regulator, has sued US Food and Drug Administration (US FDA) for revoking approvals granted to the firm for launching low-cost versions of two bestselling medicines Nexium and Valcyte used in treatment of heartburn and for infection […]

Ranbaxy Files Complaint Against FDA Over Revocation of Tentative Approvals For ANDAs For Esomeprazole Magnesium Delayed-Release Capsules And… [Global Data Point]

Nov19

Ranbaxy Files Complaint Against FDA Over Revocation of Tentative Approvals For ANDAs For Esomeprazole Magnesium Delayed-Release Capsules And Valganciclovir Hydrochloride TabletsFDA has said that its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted. As a […]

Mallinckrodt sues FDA over ADHD drug; reports Q4 loss [St. Louis Post-Dispatch]

Nov19

Nov. 19Mallinckrodt Pharmaceuticals announced Wednesday it is suing the U.S. Food and Drug Administration for the agency’s "unlawful" reclassification of its attention-deficit hyperactivity disorder drug, methylphenidate ER.The drug was previously considered, and approved, as a generic version of the branded drug Concerta until a week ago. But on Nov. 13, the FDA backtracked and told […]

Aurora Spine Corporation : AURORA SPINE RECEIVES FDA 510(k) CLEARANCE FOR PRE-PACKAGED STERILE ZIP 51(TM) MIS INTERSPINOUS FIXATION IMPLANT

Nov18

Carlsbad, California, November 18, 2014 /Marketwired/ – Aurora Spine Corporation(TSXV: ASG) announced today that it has received U.S. Food and DrugAdministration (FDA) 510(k) clearance for the ZIP 51(TM), Aurora Spine’sslimmest minimally invasive interspinous fixation implant for spinal fusion.The ZIP 51 was developed as an alternative to pedicle screw fixation anddesigned for stabilization and load sharing […]

FDA approves Roche’s Avastin plus chemotherapy to treat women with platinum-resistant recurrent ovarian cancer

Nov18

ENP Newswire – 18 November 2014Release date- 17112014 – Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Avastin (bevacizumab) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.1The approval was based on results from the Phase III AURELIA study that showed […]

Elekta’s Clarity Soft Tissue Visualization System Cleared for Use for Cancer Patients In China

Nov18

By a News Reporter-Staff News Editor at China Weekly News Men with prostate cancer will be the first group of patients inChina to benefit from the recent clearance of Elekta’s (EKTA-B.ST) Clarity? soft tissue visualization system by the China Food and Drug Administration (CFDA). As part of Elekta’s premiere linear accelerator offering, Versa HD?, Clarity […]

AdvanDx Receives FDA 510(k) Clearance for mecA XpressFISH?

Nov18

WOBURN, Mass., Nov. 18, 2014 /PRNewswire/ AdvanDx, a leader in the development of advanced molecular diagnostic products for the diagnosis and treatment of life-threatening infections, today announced that it has received U.S. Food and Drug Administration 510(k) clearance for its newmecA XpressFISH? assay for the detection of methicillin-resistantand methicillin-susceptible Staphylococcus aureus(MRSA & MSSA) direct from […]