Content about Food and Drug Administration

March 28, 2014

DSN recently launched a new microsite, DrugStoreNews.com/Pain-Management, to bring attention to a tragic side of the prescription drug abuse story — one that's not often told. The millions of Americans who live in chronic pain who already find it difficult to access the medications they need may soon find it even more difficult — because proposed changes in regulatory policy are expected to place additional hurdles on their treatment pathway.

DSN recently launched a new microsite, DrugStoreNews.com/Pain-Management, to bring attention to a tragic side of the prescription drug abuse story — one that's not often told.

March 27, 2014

In lead-up to a House Panel hearing on Thursday, the National Association of Chain Drug Stores submitted a statement expressing its support for the leadership and efforts of Congress and the Food and Drug Administration in taking common-sense approaches in safeguarding the process of delivering prescription medications to patients.

ARLINGTON, Va. — In lead-up to a House Panel hearing on Thursday, the National Association of Chain Drug Stores submitted a statement expressing its support for the leadership and efforts of Congress and the Food and Drug Administration in taking common-sense approaches in safeguarding the process of delivering prescription medications to patients.

March 26, 2014

Actavis and Valeant Pharmaceuticals International announced that the Food and Drug Administration approved the new drug application for Metronidazole 1.3% vaginal gel. The antibiotic is used for the treatment of bacterial vaginosis, an infection caused by an imbalance in the normal bacteria of vagina.

DUBLIN and LAVAL, Quebec — Actavis and Valeant Pharmaceuticals International announced that the Food and Drug Administration approved the new drug application for Metronidazole 1.3% vaginal gel.

The antibiotic is used for the treatment of bacterial vaginosis, an infection caused by an imbalance in the normal bacteria of vagina. It's the most common vaginal infection in women ages 15 years to 44 years. Metronidazole 1.3% provides a single-dose treatment that is packaged in a pre-filled disposable applicator.

March 26, 2014

GlaxoSmithKline began alerting consumers that some bottles of its Alli over-the-counter weight-loss medication have been tampered with.

MOON TOWNSHIP, Pa. — GlaxoSmithKline on Wednesday began alerting consumers that some bottles of its Alli over-the-counter weight-loss medication have been tampered with. "Consumer safety is GSK's primary concern," the company stated. "We have initiated an investigation and are working with the Food and Drug Administration."

The outer carton of any tampered product may look authentic, but there are several tell-tale signs that the product has been tampered with, GSK cautioned, including:  

March 25, 2014

The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL.

SILVER SPRING, Md. — The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL. 

Atovaquone is the generic equivalent of GlaxoSmithKline's Mepron, indicated for the prevention of Pneumocystis jiroveci pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.

March 25, 2014

Mylan on Monday announced the U.S. District Court for the Northern District of West Virginia ruled in favor of upholding the validity of patents protecting Perforomist (formoterol fumarate) Inhalation Solution.

PITTSBURGH — Mylan on Monday announced the U.S. District Court for the Northern District of West Virginia ruled in favor of upholding the validity of patents protecting Perforomist (formoterol fumarate) Inhalation Solution. Mylan previously sued Teva alleging that Teva's abbreviated new drug application for this product infringed four Mylan patents covering Perforomist.  

The court's decision prevents Teva's ANDA, which has yet to receive a tentative approval from the Food and Drug Administration. 

March 24, 2014

Genentech announced that the Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, or CIU, which is a form of chronic hives.

SOUTH SAN FRANCISCO, Calif. — Genentech announced that the Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, or CIU, which is a form of chronic hives.

CIU is diagnosed when hives occur without cause, spontaneously present and reoccur for more than six weeks, the company said. The symptoms include swelling, severe itch, pain and discomfort that may last for months and, in some cases, years. 

March 24, 2014

Celgene on Friday announced that the Food and Drug Administration has approved Otezla (apremilast), the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis.

SUMMIT, N.J. — Celgene on Friday announced that the Food and Drug Administration has approved Otezla (apremilast), the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning. Otezla is the only FDA-approved oral treatment for psoriatic arthritis.

March 21, 2014

Actavis earlier this week announced that it has entered into an agreement with Noven Pharmaceuticals to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system).

DUBLIN — Actavis earlier this week announced that it has entered into an agreement with Noven Pharmaceuticals to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system). Daytrana is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder.

March 20, 2014

The Food and Drug Administration announced the approval of Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites.

SILVER SPRING, Md. — The Food and Drug Administration announced the approval of Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites. It's the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.

March 19, 2014

The Electronic Retailing Self-Regulation Program on Tuesday announced it will refer direct response advertising for Dinamo to the Federal Trade Commission and the Food and Drug Administration after the marketer, Natures Flava, failed to respond to an ERSP inquiry.

NEW YORK — The Electronic Retailing Self-Regulation Program on Tuesday announced it will refer direct response advertising for Dinamo to the Federal Trade Commission and the Food and Drug Administration after the marketer, Natures Flava, failed to respond to an ERSP inquiry.

March 19, 2014

Ferring Pharmaceuticals announced that it received approval from the Food and Drug Administration for new labeling of its fertility products Menopur and Bravelle.

PARSIPPANY, N.J. — Ferring Pharmaceuticals announced that it received approval from the Food and Drug Administration for new labeling of its fertility products Menopur and Bravelle. The update is a result of the Combine trial, which showed that both Menopur and Bravelle can be safely mixed and administered in a single injection.

March 18, 2014

Avella Specialty Pharmacy announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act.

PHOENIX — Avella Specialty Pharmacy on Tuesday announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act. Outsource facilities must consent to greater federal oversight including more frequent inspections and are required to demonstrate their adherence to specific “good manufacturing practices,” Avella noted. 

March 18, 2014

The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning.

AMELIA ISLAND, Fla. — The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning. 

March 18, 2014

Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

DUBLIN — Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

The drug also is indicated for patients for whom alternative treatments have shown to be ineffective. Xartemis XR, previously known as MNK-795, is the first and only extended-release oral combination of two clinically proven pain medications — oxycodone and acetaminophen.

March 18, 2014

Natco Pharma received tentative approval from the Food and Drug Administration to launch a generic version of Roche Holding AG's Tamiflu, according to a recent report. The drug is used to treat bird and swine flu.

HYDERABAD — Natco Pharma received tentative approval from the Food and Drug Administration to launch a generic version of Roche Holding AG's Tamiflu, according to a recent report. The drug is used to treat bird and swine flu.

March 18, 2014

Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday.

NEW YORK — Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday

Torrent has filed an aNDA with the Food and Drug Administration, challenging Pfizer's patent that expires on Oct. 22, 2019. 

March 17, 2014

Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.

PRINCETON, N.J. and NEW YORK — Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.  

March 17, 2014

Pierre Fabre Dermatologies announced that it received authorization from the Food and Drug Administration to market the pediatric drug Hemangeol (propranolol hydrochloride).

CASTRES, France and PARSIPPANY, N.J. — Pierre Fabre Dermatologies announced that it received authorization from the Food and Drug Administration to market the pediatric drug Hemangeol (propranolol hydrochloride).

It is the first and only approved treatment for “proliferating infantile hemangioma requiring systemic therapy," the company said. Infantile hemangioma is a vascular benign tumor that affects 3% to 10% of newborns.

March 14, 2014

Legislation introduced to unclog the backlog of sunscreen ingredients and streamline the review process for faster public access has garnered the accolades of the Public Access to SunScreen Coalition.

WASHINGTON — Legislation introduced to unclog the backlog of sunscreen ingredients and streamline the review process for faster public access has garnered the accolades of the Public Access to SunScreen Coalition.

March 13, 2014

Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

COLUMBIA, S.C. — Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

The research was published in the March/April issue of Annals of Family Medicine.

March 12, 2014

Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

MAPLE GROVE, Minn. — Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

Qudexy XR will be available to patients in second quarter 2014.

March 12, 2014

Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

WASHINGTON, D.C. — Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

March 10, 2014

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines. By the end of this decade, a significant number of blockbuster drugs will go off patent, paving the way for biosimlar market entrance.

March 10, 2014

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy.

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy. They both address chronic care needs, and they both represent first of their kind medicines to the nonprescription aisle.