K-V Pharmaceutical Loses FDA Lawsuit Over Makena Drug #pharma #d

Posted On May 18 2017 by

#kv pharma # K-V Pharmaceutical Loses FDA Lawsuit Over Makena Drug K-V Pharmaceutical Co.’s lawsuit alleging that the U.S. Food and Drug Administration’s actions led to “unlawful competition” involving its Makena drug was dismissed by a federal judge. U.S. District Judge Amy Berman Jackson in Washington today threw out the company’s claims that the FDA caused it “irreparable harm” by refusing to block pharmacies that created a cheaper alternative of the drug used to reduce the risk of pre-term birth in women. “This case is fundamentally an effort to get the court to direct and oversee the FDA’s enforcement activities, …


FDA Adds Three Chinese Pharma Companies to Import Alert Lists #pharma #equipment

Posted On May 17 2017 by

#chinese pharmaceutical companies # Pharma Manufacturing FDA Adds Three Chinese Pharma Companies to Import Alert Lists More News: Join the discussion Free Subscriptions Most Popular Novartis’ Alcon Penalized $16M for Illegal Exports to Iran 2016 Contract Pharma Trends Ebook FDA OK’s Novartis Biosimilar to Amgen Arthritis Drug, Enbrel Valeant Sued for Alleged Racketeering, Linked to Philidor Novo Nordisk CEO Steps Down 2016 Contract Pharma Trends Ebook Mylan Under Fire for Huge Price Hikes on More than Just Its EpiPen Work for this Biotech Startup, Get a Free Tesla Car FDA Warns China API Maker for Hiding Quality Testing Data Innovation …


Tris Pharma Receives FDA Approval of Dyanavel™ XR (amphetamine) CII as Once-Daily Liquid for #novadel #pharma

Posted On May 13 2017 by

#tris pharma # Tris Pharma Receives FDA Approval of Dyanavel™ XR (amphetamine) CII as Once-Daily Liquid for Treatment of ADHD in Children MONMOUTH JUNCTION, N.J. Oct. 20, 2015 /PRNewswire/ — Tris Pharma, Inc. (“Tris”) announced that the U.S. Food and Drug Administration (“FDA”) has approved Dyanavel XR (amphetamine), extended-release oral suspension, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years and older. With this approval, Dyanavel XR becomes the only once-daily, extended release amphetamine-based oral liquid approved for the treatment of ADHD in children. The approval is based on a Phase III randomized, placebo-controlled, laboratory classroom efficacy …


FDA Takes Action Against KV Pharmaceutical Company #pharma #brands

Posted On May 2 2017 by

#kv pharma # Media Inquiries:Rita Chappelle, 301-796-4672Consumer Inquiries:888-INFO-FDA FDA Takes Action Against KV Pharmaceutical CompanyCompany Making, Marketing and Distributing Adulterated and Unapproved Drugs The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA’s current …


FDA bans imports from Sun Pharma plant in India crackdown #sandoz #pharma

Posted On May 1 2017 by

#sun pharma # FDA bans imports from Sun Pharma plant in India crackdown By Zeba Siddiqui and Sumeet Chatterjee | MUMBAI MUMBAI (Reuters) – The U.S. Food and Drug Administration (FDA) has banned imports from Indian generic drugmaker Sun Pharmaceutical Industries Ltd’s plant at Karkhadi in the western state of Gujarat, in the latest quality blow for India’s drug sector. The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market. …


MDS Pharma closes Quebec facility following FDA probe #biotechnology #industry

Posted On Apr 24 2017 by

#mds pharma services # MDS Pharma closes Quebec facility following FDA probe By Kirsty Barnes Kirsty Barnes 06-Feb-2007 2007-02-06T00:00:00Z MDS pharma has ceased operations at its bioanalytical services facility in Blainville, Quebec in a bid to boost profitability after an ongoing investigation of the site by the US Food and Drug Administration (FDA). The restructure also affects the firm’s other North American bioanalytical facilities – in St. Laurent, Montreal, which is also involved in the FDA probe, as well as its site in Lincoln, Nebraska. From now on, the former Quebec operations will be carried out from the Montreal facility, …


FDA Adds Three Chinese Pharma Companies to Import Alert Lists #purdue #pharmaceutical

Posted On Apr 21 2017 by

#chinese pharmaceutical companies # Pharma Manufacturing FDA Adds Three Chinese Pharma Companies to Import Alert Lists More News: Join the discussion Free Subscriptions Most Popular Novartis’ Alcon Penalized $16M for Illegal Exports to Iran 2016 Contract Pharma Trends Ebook FDA OK’s Novartis Biosimilar to Amgen Arthritis Drug, Enbrel Valeant Sued for Alleged Racketeering, Linked to Philidor Novo Nordisk CEO Steps Down 2016 Contract Pharma Trends Ebook Mylan Under Fire for Huge Price Hikes on More than Just Its EpiPen Work for this Biotech Startup, Get a Free Tesla Car FDA Warns China API Maker for Hiding Quality Testing Data Innovation …


Promius Pharma – Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, % #top #drug #manufacturers

Posted On Apr 16 2017 by

#promius pharma # Promius Pharma™ Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05% February 07, 2016 11:52 PM Eastern Standard Time HYDERABAD, India & PRINCETON, N.J.–( BUSINESS WIRE )–Dr. Reddy’s announced today that its US subsidiary, Promius Pharma TM. LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the …


FDA Adds Three Chinese Pharma Companies to Import Alert Lists #boehringer #pharmaceuticals

Posted On Apr 12 2017 by

#chinese pharmaceutical companies # Pharma Manufacturing FDA Adds Three Chinese Pharma Companies to Import Alert Lists More News: Join the discussion Free Subscriptions Most Popular Novartis’ Alcon Penalized $16M for Illegal Exports to Iran 2016 Contract Pharma Trends Ebook FDA OK’s Novartis Biosimilar to Amgen Arthritis Drug, Enbrel Valeant Sued for Alleged Racketeering, Linked to Philidor Novo Nordisk CEO Steps Down 2016 Contract Pharma Trends Ebook Mylan Under Fire for Huge Price Hikes on More than Just Its EpiPen Work for this Biotech Startup, Get a Free Tesla Car FDA Warns China API Maker for Hiding Quality Testing Data Innovation …


K-V Pharmaceutical Loses FDA Lawsuit Over Makena Drug #avema #pharma #solutions

Posted On Apr 5 2017 by

#kv pharma # K-V Pharmaceutical Loses FDA Lawsuit Over Makena Drug K-V Pharmaceutical Co.’s lawsuit alleging that the U.S. Food and Drug Administration’s actions led to “unlawful competition” involving its Makena drug was dismissed by a federal judge. U.S. District Judge Amy Berman Jackson in Washington today threw out the company’s claims that the FDA caused it “irreparable harm” by refusing to block pharmacies that created a cheaper alternative of the drug used to reduce the risk of pre-term birth in women. “This case is fundamentally an effort to get the court to direct and oversee the FDA’s enforcement activities, …