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Boehringer Ingelheim: Benefits and Safety of Pradaxa Repeatedly Confirmed

Posted yesterday in Pharma Industry News

Ridgefield, CT, July 23, 2014 – Boehringer Ingelheim (BI) wants to set the record straight following misleading statements that the British Medical Journal (BMJ) published today regarding Pradaxa® (dabigatran etexilate mesylate). We are concerned that this publication may alarm patients and prompt them to stop taking Pradaxa, thereby increasing their risk of stroke. To be clear, many of the allegations made by BMJ were reported months ago in the media and have been previously addressed in...

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FDA announces voluntary nationwide recall of all non-expired sterile drugs from Unique Pharmaceuticals

Posted yesterday in Pharma Industry News

July 23, 2014 -- The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas. The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products. Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique...

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FDA Consumer Advice on Powdered Pure Caffeine

Posted 3 days ago in Pharma Industry News

July 21, 2014 -- The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products. In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet. The FDA is aware of at least one death of a teenager who used these products. These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee. Pure caffeine is a...

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Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs

Posted 6 days ago in Pharma Industry News

July 17, 2014 -- The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act. Agents from FDA’s Office of Criminal Investigations worked closely with the U.S. Drug Enforcement...

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Popping Pills in America: Can the DEA Fix This?

Posted 10 days ago in Pharma Industry News

There's no doubt about it - the U.S. is a big consumer of prescription painkillers. In fact, in 2010 enough prescription painkillers were prescribed to medicate each American adult every four hours for an entire month. A report released in March 2014 from the U.S. National Safety Council shows that prescription drug overdoses – more than car accidents – are the leading cause of accidental death among U.S. working-age adults. According to the Centers for Disease Control and Prevention (CDC),...

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DEA: Placement of Tramadol Into Schedule IV

Posted 2 weeks ago in Pharma Industry News

July 11, 2014 -- The U.S. Drug Enforcement Administration (DEA) has announced tramadol has been placed into schedule IV of the Controlled Substances Act (CSA) effective August 18, 2014. The new scheduling applies to all tramadol salts, isomers, and salts of isomers. This action imposes the regulatory controls applicable to schedule IV controlled substances on persons who handle or propose to handle tramadol. The Controlled Substances Act (CSA) is the federal U.S. drug policy under which...

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Mylan Launches Generic Micardis Tablets

Posted 2 weeks ago in Pharma Industry News

PITTSBURGH, July 8, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Telmisartan Tablets USP, 20 mg, 40 mg and 80 mg, the generic version of Boehringer Ingelheim's Micardis® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of hypertension, to lower blood pressure. Telmisartan Tablets USP, 20 mg, 40 mg and 80 mg, had...

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Human Anti-human PD-1 Monoclonal Antibody Opdivo Approved in Japan for Unresectable Melanoma

Posted 2 weeks ago in Pharma Industry News

July 4, 2014 -- Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director and CEO, Gyo Sagara; “ONO”) announced that ONO has today received manufacturing and marketing approval for the human anti-human PD-1 monoclonal antibody Opdivo® Intravenous Infusion 20 mg/100 mg(Opdivo) for the treatment of unresectable melanoma. Melanoma is considered to be a form of tumor characterized by the malignant transformation of pigment-producing cells located in the skin. In Japan,...

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Federal Judge Approves Consent Decree with New York Dietary Supplement Maker

Posted 3 weeks ago in Pharma Industry News

July 2, 2014 -- A federal judge in New York has signed a consent decree for permanent injunction between the United States and Mira Health Products Ltd., a dietary supplement manufacturer located in Farmingdale, New York, and Michael S. Ragno and Michael S. Ragno, Jr. On July 26, 2013, the FDA issued a warning to consumers not to use or purchase Healthy Life Chemistry By Purity First B-50, a dietary supplement manufactured by Mira. The FDA issued this warning after receiving numerous reports...

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FDA seeks permanent injunction against California pharmaceutical company

Posted 3 weeks ago in Pharma Industry News

July 1, 2014 -- On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico. The complaint claims that Laclede illegally distributes over-the-counter vaginal drug products without required FDA approval. According to the complaint, Laclede is...

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FDA outlines expectations for human drug compounders, including registered outsourcing facilities

Posted 3 weeks ago in Pharma Industry News

July 1, 2014 -- Today, the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists. “Providing clarity to the...

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Monthly News Roundup - June 2014

Posted 3 weeks ago in Pharma Industry News

Afrezza Inhaled Insulin FDA-Approved for Type 1 and Type 2 Diabetics The U.S. Food and Drug Administration (FDA) has approved Afrezza (insulin human) Inhalation Powder to improve glycemic control in adult diabetics. Afrezza is an ultra rapid-acting inhaled insulin that is administered with meals. Afrezza was evaluated in 24-week studies in both type 1 and type 2 diabetic patients. In type 1 patients also using long-acting insulin, Afrezza effectiveness to lower blood sugar (HbA1c) provided...

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Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma

Posted 3 weeks ago in Pharma Industry News

WHITEHOUSE STATION, N.J.-June 30, 2014-(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company’s investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved by the European Commission (EC), pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional...

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Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma

Posted 3 weeks ago in Pharma Industry News

WHITEHOUSE STATION, N.J.-June 30, 2014-(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company’s investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved by the European Commission (EC), pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional...

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Ohm Laboratories To Launch Valsartan Tablets

Posted 4 weeks ago in Pharma Industry News

New Brunswick: NJ–Jun 27, 2014- Ohm Laboratories, Inc. (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that Ohm has received approval from the U.S. Food and Drug Administration to manufacture and market Valsartan 40 mg, 80 mg, 160 mg, and 320 mg tablets on an exclusive basis. Valsartan is indicated for the treatment of high blood pressure and heart failure. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ohm...

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Mylan Launches Generic Actonel Tablets, 150 mg

Posted 6 weeks ago in Pharma Industry News

PITTSBURGH, June 11, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Risedronate Sodium Tablets USP, 150 mg, the generic version of Warner Chilcott's Actonel® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Risedronate Sodium Tablets USP, 150 mg, had U.S. sales...

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FDA Approves Expanded Label for Azilect for Treatment Across All Stages of Parkinson’s Disease

Posted 6 weeks ago in Pharma Industry News

JERUSALEM--(BUSINESS WIRE)--Jun. 9, 2014-- Teva Pharmaceutical Industries Ltd. today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Azilect (rasagiline tablets) from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs). The new indication reflects that Azilect can be used alone or in combination with other Parkinson’s disease (PD) medications. The approval reinforces the growing clinical evidence demonstrating the...

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FDA Approves First Generic Versions of Celecoxib

Posted 7 weeks ago in Pharma Industry News

May 30, 2014 -- The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions. Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to...

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Monthly News Roundup - May 2014

Posted 7 weeks ago in Pharma Industry News

Durata’s Once-a-Week Antibiotic Dalvance Approved for Skin Infections The U.S. Food and Drug Administration has approved injectable Dalvance (dalbavancin), an antibiotic used to treat adults with acute bacterial skin and skin structure infections caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes. Dalvance is the first drug FDA-designated as a Qualified Infectious Disease Product (QIDP), intended to...

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U.S. Marshals Seize Unapproved Drugs from Ohio Distributor

Posted 9 weeks ago in Pharma Industry News

May 16, 2014 -- U.S. Marshals, at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, have seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio. The seized products include: Pramoxine-HC Otic Drops, intended to treat infections of the external ear caused by microbes and to control itching; Hydrocortisone Acetate...

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