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 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 […]

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 The FDA has also withdrawn six-month market exclusivity of Valcyte.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 […]

Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51(TM) MIS Interspinous Fixation Implant

Nov18

CARLSBAD, CALIFORNIA (Marketwired) 11/18/14 Aurora Spine Corporation (TSX VENTURE: ASG) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ZIP 51™, Aurora Spine’s slimmest minimally invasive interspinous fixation implant for spinal fusion.The ZIP 51 was developed as an alternative to pedicle screw fixation and designed for stabilization and […]

IlluminOss Medical Announces Conditional FDA Approval for Clinical Trials of Groundbreaking Photodynamic Bone Stabilization System in the U.S.

Nov18

EAST PROVIDENCE, RI (Marketwired) 11/18/14 IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received conditional approval from the FDA to conduct a clinical trial for the treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma. IlluminOss expects to […]

FDA approves trade name Auryxia for Keryx’s ferric citrate [EMBIN (Emerging Markets Business Information News]

Nov18

The US Food and Drug Administration (FDA) has approved the trade name Auryxia (ferric citrate) for Keryx Biopharmaceuticals’ FDA-approved ferric citrate.Keryx is a biopharmaceutical firm focused on bringing new therapies to market for patients with renal disease.In September 2014, Auryxia was approved by the FDA to control serum phosphorus levels in patients with chronic kidney […]

Bio-Rad Receives Premarket Application Approval for Its Geenius HIV 1/2 Supplemental Assay

Nov18

HERCULES, CA (Marketwired) 11/18/14 Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a global provider of life science research and clinical diagnostic products life science research and clinical diagnostic products, today announced that it has received Premarket Application approval from the U.S. Food and Drug Administration for Bio-Rad’s Geenius™ HIV 1/2 Supplemental Assay (test).The Geenius […]