Regulatory and Drug Approvals News
Regulatory Affairs and Drug Approvals News
Advanced Life Sciences Applies For FDA Fast-Track Designation For Restanza In CABP
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced that the Company has applied to the U.S...
Abbott's SIMCOR ® ( Niacin Extended-release / Simvastatin ) Receives FDA Approval For New Dosage Strengths
Abbott (NYSE: ABT) received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin the most commonly prescribed dose of simvastatin with either 500 mg or 1,000 mg of niacin extended-release...
Encap Drug Delivery Receives Patent Approval For DuoCapTM Capsule System
Encap Drug Delivery, a leading provider of development and manufacturing services to the pharmaceutical industry, has received confirmation that their DuoCapTM, capsule delivery system has been granted patents for US and Europe. DuoCapTM, is a single oral dosage unit that comprises a capsule-in-a-capsule and offers broad therapeutic applications...
Abbott's SIMCOR ® ( Niacin Extended-release / Simvastatin ) Receives FDA Approval For New Dosage Strengths
Abbott (NYSE: ABT) received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin the most commonly prescribed dose of simvastatin with either 500 mg or 1,000 mg of niacin extended-release...
Advanced Life Sciences Applies For FDA Fast-Track Designation For Restanza In CABP
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced that the Company has applied to the U.S...
FDA Approves Drug For Chronic Drooling In Children
The U.S. Food and Drug Administration approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years. Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by neuromuscular dysfunction that makes it hard to swallow...
Encap Drug Delivery Receives Patent Approval For DuoCapTM Capsule System
Encap Drug Delivery, a leading provider of development and manufacturing services to the pharmaceutical industry, has received confirmation that their DuoCapTM, capsule delivery system has been granted patents for US and Europe. DuoCapTM, is a single oral dosage unit that comprises a capsule-in-a-capsule and offers broad therapeutic applications...
New Early Detection System Helps FDA Identify More Than 100 Food Safety Problems In First 7 Months
More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration's new electronic portal in its first months of operation, the agency said today...
FDA Grants Priority Review To Cladribine Tablets For The Treatment Of Relapsing Forms Of MS
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS)...
PhRMA Asks FDA To Be More Straightforward On Safeguards It Wants To Fight Drug Risks
The pharmaceutical industry trade group PhRMA said Monday that the Food and Drug Administration should do a better job of explaining additional safeguards it mandates against certain drugs when it issues warnings, Reuters reports...
