Over The Counter (OTC) Drug News and Research

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KemPharm to formulate and develop KP106 as oral film dosage for ADHD treatment

KemPharm, Inc. today announced that KP106, its clinical candidate for Attention Deficit/Hyperactivity Disorder, will be formulated and developed in an oral film dosage form pursuant to an exclusive collaboration agreement with MonoSol Rx relating to the development, commercialization and manufacture of KP106.

26 Apr 2011

MonoSol Rx, KemPharm enter development and commercialization partnership for ADHD prodrug

MonoSol Rx, LLC, the developer of PharmFilm® drug delivery technology, today announced that the Company has entered into a development and commercialization partnership with KemPharm, a biopharmaceutical company focused on the discovery and development of new, safer therapies for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), pain, and cardiovascular disease.

25 Apr 2011

FDA warns four firms to stop making unproven MRSA prevention claims

The U.S. Food and Drug Administration issued four warning letters to companies that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA).

21 Apr 2011

MonoSol Rx receives positive FDA feedback on 505(b)(2) pathway for Montelukast Sodium OSF

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, today announced that it held a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of Montelukast Sodium Oral Soluble Film (OSF) under a 505(b)(2) pathway.

30 Mar 2011

FDA announces consent decree of permanent injunction against Deltex

The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.

19 Jan 2011

MonoSol Rx granted U.S. patent for PharmFilm and production technologies

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, today announced that it has been granted U.S. patent No. 7,824,588 from the United States Patent and Trademark Office (USPTO). The patent, issued on November 2, 2010, provides intellectual property protection for the Company's film products and methods of their preparation.

10 Nov 2010

Federal Government seizes prescription and OTC drug products from Tri-Med Labs

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized articles of prescription and over-the-counter (OTC) drug products from Tri-Med Laboratories Inc. in Somerset, N.J. earlier this month. The seizure warrant, issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.

28 Oct 2010

FDA issues warning letters to three companies for claiming plaque removal by mouth rinse products

The FDA today issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

29 Sep 2010

Stroke risk with common pain killers dismissed by manufacturer

An eight-year Danish study, which involved more than 2.5 million healthy Danes found there was a higher risk of stroke for those taking high doses of ibuprofen, which is in the painkiller Nurofen. The manufacturers of Nurofen, Reckitt Benckiser, have dismissed these reports. The spokesperson for the company said, “it is important to note that the conclusions drawn by the study authors are based on high doses of ibuprofen…The results of this study should not be confused with non-prescription low doses of NSAIDs, such as ibuprofen, which are available over-the-counter and used by millions of people around the world, for short periods of time, every day.”

14 Sep 2010

Midatech Group, MonoSol Rx file patent to enable commercialization of drug delivery technology

Midatech Group Ltd., a global leader for the design, development, synthesis and manufacture of nanomedicines, and MonoSol Rx, the leader in developing and manufacturing pharmaceutical films based on its proprietary PharmFilm drug delivery technology, today announced the filing of a provisional US patent application for "Nanoparticle Film Delivery Systems." The applications submitted to the United States Patent and Trademark Office (USPTO) relate to therapeutic uses of nanoparticle-based proteins and peptides delivered in pharmaceutical films.

18 Aug 2010

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, in collaboration with APR Applied Pharma Research s.a. of Switzerland and Labtec GmbH of Germany, today announced that its partner, Strativa Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for Zuplenz® oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

8 Jul 2010

MonoSol Rx, Midatech collaborate to develop peptides for therapeutic delivery utilizing pharmaceutical films

MonoSol Rx, the developer of PharmFilm® drug delivery technology, today announced the expansion of its agreement with Midatech Group (Oxford, UK) to develop nanoparticle-based proteins and peptides for therapeutic delivery utilizing pharmaceutical films. Under the terms of the expanded agreement, MonoSol Rx has made an equity investment in Midatech and Keith Kendall, Executive Vice President and Chief Financial Officer of MonoSol Rx, will join the Midatech Board of Directors.

24 Jun 2010

MonoSol Rx, APR expand film formulation development collaboration

MonoSol Rx, the developer of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, and APR Applied Pharma Research s.a. ("APR") announced today an expansion of their relationship to identify and develop film formulations of prescription drug products beyond ondansetron and donepezil to include zolmitriptan. Zolmitriptan is currently commercially available for the acute treatment of migraine headache in adults, and facing initial patent expirations in 2012.

10 Jun 2010

Investigations on Tylenol recall from House Committee

Following the massive recall of children’s and infants’ fever medicine Tylenol and other over the counter drugs (like Motrin, Benadryl and Zyrtec) for children a congressional committee has urged an investigation into the problem.

6 May 2010

Fifth Community Pharmacy Agreement planned by the Pharmacy Guild of Australia

According to an Australian Financial Review report the major pharmaceutical companies have agreed to reduce the Australian government’s medicine bill by AUD $2 billion over the next four years only if they are assured of price modifications in future. The details of the agreement are to be revealed next week and experts believe it will reduce the burden on the federal budget which is still considering the source of funds to pay for its health reform package.

4 May 2010

Codeine containing preparations lose their OTC status

It will get more difficult to procure Codeine based pain killers, cough syrups etc. from the local pharmacists from now on. There have been new restrictions over codeine based drugs like Nurofen Plus, Panadeine and Mersyndol which were initially sold over the counter but lost this OTC status with effect from May 1st 2010. The National Drugs and Poisons Schedule Committee formulated the changes during meetings in June and October last year.

2 May 2010

Britain popping “pills for every ill”, says research

A new study reports that Britons are turning to prescription drugs for every illness, minor or major. This recent paper titled “A Pill for Every Ill”, published in Social Science & Medicine journal says that while two decades earlier average number of prescriptions dispensed per person was only eight, it is more than 16 now.

30 Mar 2010

MonoSol Rx signs new licensing and development agreement with Strativa Pharmaceuticals

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, announced today that it has entered into a new licensing and development agreement that grants the option to develop three new products with Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. ( PRX).

6 Jan 2010

Muscle rubs for pain in adults – no evidence they work

There is not enough evidence to support using gels and creams containing rubefacients for chronic and acute pain, according to a systematic review by Cochrane Researchers. Rubefacients cause irritation and reddening of the skin, due to increased blood flow. The review focused on formulations containing salicylates, which are widely prescribed or sold over the counter as topical treatments for sports injuries and muscle pain.

7 Jul 2009

Warnings about ‘over-use’ of paracetamol

A panel of experts in the United States has raised new concerns about the popular painkiller paracetamol and are calling for the Food and Drug Administration (FDA) to reduce the maximum dose of paracetamol allowed because they say 'over-use' can cause serious liver damage.

5 Jul 2009