Approvals
The Lead
FDA Approves New Multiple Sclerosis Capsules
March 28, 2013 8:10 am | News | Comments
The U.S. Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to control multiple sclerosis in adults with hard-to-treat forms of the disease.The twice-a-day capsules, called Tecfidera, offer a new option for multiple sclerosis, a debilitating disease in which the body attacks its own nervous system.
FDA Approves New Multiple Sclerosis Capsules
March 28, 2013 8:10 am | News | Comments
The U.S. Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to...
FDA OKs Drug for Painful Sex Caused by Menopause
February 27, 2013 7:53 am | News | Comments
The Food and Drug Administration on Tuesday approved the first pill-based drug for women who...
FDA OKs Drug for Painful Sex Caused by Menopause
February 27, 2013 7:53 am | News | Comments
The Food and Drug Administration on Tuesday approved the first pill-based drug for women who...
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Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.
May 17, 2013 7:57 am | News | CommentsOramed Pharmaceuticals Inc. a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.
US Approves Radiation-Based Prostate Cancer Drug
May 16, 2013 8:28 am | News | CommentsThe U.S. Food and Drug Administration has approved a new injectable drug that uses radiation to treat advanced prostate cancer that has spread to the bones. The FDA said Wednesday it approved the drug, Xofigo from Bayer Pharmaceuticals, for men whose cancer has grown into bone tumors even after receiving medication or surgery to lower testosterone.
SIMPONI Receives FDA Approval for Ulcerative Colitis
May 16, 2013 8:17 am | News | CommentsJanssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.
Cubist Antibiotic Regimen Gets Fast-Track Review
May 8, 2013 8:10 am | News | CommentsCubist Pharmaceuticals Inc. said Tuesday that the Food and Drug Administration has given fast-track status to an experimental antibiotic regimen as a treatment for three types of infections. The company is studying a combination of ceftolozane and tazobactam as a treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia as well as complicated urinary-tract infections.
FDA Approves Merck Combination Cholesterol Pill
May 3, 2013 5:56 pm | by The Associated Press | News | CommentsWHITEHOUSE STATION, N.J. (AP) — Merck & Co. said Friday that it received U.S. marketing approval for the new combination cholesterol drug Liptruzet, which combines the company's drug Zetia with a generic version of the mega-blockbuster drug Lipitor. The Food and Drug Administration approved...
FDA OKs Bristol's HIV Drug for Younger Patients
May 3, 2013 5:51 pm | by The Associated Press | News | CommentsBristol-Myers Squibb Co. said Friday that U.S. regulators expanded approval of its HIV drug Sustiva to children as young as three months old. The capsule-based drug was first approved in 1998 to treat HIV-infected children who are age three and older and weigh at least 22 pounds. The new approval...
FDA Approves Bristol-Myers Squibb’s sNDA for Use of SUSTIVA® (efavirenz) in HIV-1 Infected Pediatric Patients
May 3, 2013 8:32 am | News | CommentsBristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for SUSTIVA ® (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.
Hyperion Therapeutics Drug Gets FDA Orphan Status
May 3, 2013 8:20 am | News | CommentsHyperion Therapeutics Inc. said Thursday that its drug Ravicti received orphan drug status, giving the drug seven years of marketing exclusivity. Ravicti was approved Feb. 1 as a treatment for urea cycle disorders, a rare type of enzyme deficiency, in patients 2 years and older. The Food and Drug Administration's decision to grant orphan drug status will keep similar products off the market until Feb. 1, 2020.
Teva's Plan B to Move Over-the-Counter
May 1, 2013 8:39 am | News | CommentsThe FDA announced on Tuesday that it lowered to 15 the age at which women can buy Teva’s Plan B One-Step (levonorgestrel) emergency oral contraceptive and also allowed the drug to be available over-the-counter without a prescription. Previously, only those aged 17 or older could obtain the emergency oral contraceptive without a prescription.
FDA Approves Kcentra for the Reversal of Anticoagulation In Adults
April 30, 2013 9:32 am | News | CommentsThe U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.
FDA Clears Noninvasive Ventilation Device for COPD Treatment
April 25, 2013 9:05 am | News | CommentsThe Food and Drug Administration recently cleared ResMed's home variable positive airway pressure (VPAP) device — also known as bilevel PAP — for the treatment of respiratory disorders such as COPD, giving severe COPD sufferers a weapon in the fight to stay out of the hospital.
Merck Announces Breakthrough Therapy Designation for Advanced Melanoma
April 24, 2013 9:32 am | News | CommentsMerck announced the FDA has designated lambrolizumab as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck's investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types.
Health Canada Approves PERJETA for Treatment of HER2-positive Metastatic Breast Cancer
April 23, 2013 3:52 pm | News | CommentsPERJETA (pertuzumab), in combination with the current standard of care, HERCEPTIN® (trastuzumab) and docetaxel chemotherapy, is approved for the treatment of patients with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
FDA Approves Anti-constipation Pill from Sucampo
April 23, 2013 11:18 am | by The Associated Press | News | CommentsSucampo Pharmaceuticals Inc. and Takeda Pharmaceuticals said Tuesday that they received U.S. regulatory to market their constipation treatment Amitiza for a new use. The Food and Drug Administration approved the pill for constipation caused by opioid pain medications used by patients with...
Teva and Xenon Announce FDA Orphan Drug Designation for Pain Drug
April 23, 2013 9:09 am | News | CommentsTeva Pharmaceutical Industries Ltd. and Xenon Pharmaceuticals Inc. announced today that the FDA has granted orphan-drug designation to the investigational drug XEN402 being developed for the treatment of pain associated with erythromelalgia.
FDA Approves Second Drug in BD SimplistT Line of Products
April 23, 2013 9:00 am | News | CommentsBD Rx Inc. announced that the FDA has approved the second drug to be offered in the recently launched BD SimplistT line of ready-to-administer prefilled generic injectables. The second BD Simplist product to launch is Metoclopramide Injection, USP, an injectable antiemetic.
FDA Approves Neuralstem to Treat Final Cohort in NSI-189 Phase Ib Trial
April 22, 2013 9:32 am | News | CommentsNeuralstem, Inc. announced that it has received approval from the Food and Drug Administration (FDA) to begin dosing the third and final cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD).
Amarin Announces Approval of sNDA for Chemport as Additional Vascepa(R) API Supplier
April 18, 2013 8:06 am | News | CommentsAmarin Corporation plc, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the approval of the Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to add Chemport, Inc. as an additional Vascepa(R) (icosapent ethyl) active pharmaceutical ingredient (API) supplier.
VIVUS Announces FDA Approval of Qsymia REMS Modification Allowing Access Through Certified Retail Pharmacies
April 17, 2013 8:24 am | News | CommentsVIVUS has announced that the FDA has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia capsules CIV. The amendment, submitted in October 2012, allows Qsymiato be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies.
FDA Approves Abuse-Deterrent Labeling for Reformulated OxyContin
April 17, 2013 8:09 am | News | CommentsThe FDA has approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).
Taro Says FDA Approves Psoriasis Treatment Spray
April 12, 2013 5:46 pm | by The Associated Press | News | CommentsTaro Pharmaceutical Industries Ltd. said Friday the Food and Drug Administration approved its Topicort spray as a treatment for plaque psoriasis. The company said Topicort, or desoximetasone, is approved for patients age 18 and older. Taro said U.S. consumers spend about $100 million per year on...
Maryland Lawmakers Pass Medical Marijuana Bill
April 9, 2013 8:21 am | by BRIAN WITTE,Associated Press | News | CommentsThe Maryland General Assembly on Monday approved a measure allowing medical marijuana programs at research centers that choose to participate. The state Senate approved the measure, 42-4. Ten of the Senate's 12 Republicans joined 32 Democrats, while two Democrats and two Republicans voted against it.
FDA Approves Return of Drug for Morning Sickness
April 9, 2013 7:59 am | by LAURAN NEERGAARD,AP Medical Writer | News | CommentsA treatment pulled off the market 30 years ago has won Food and Drug Administration approval again as the only drug specifically designated to treat morning sickness. That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.
Genzyme’s AUBAGIO® Approved in Argentina for the Treatment of Relapsing MS
April 8, 2013 9:42 am | News | CommentsGenzyme, a Sanofi company, announced today Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO® 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS).
FDA Approves Tris Pharma's New Drug Application for Karbinal ER Extended-release Oral Suspension
April 3, 2013 7:51 am | News | CommentsTris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the FDA has approved its New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.
