Content about Food and Drug Administration

April 3, 2014

The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. 

April 2, 2014

Greer Labs, a developer and provider of allergy immunotherapy products and services, announced that the Food and Drug Administration has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass mixed pollens allergen extract) sublingual allergy immunotherapy tablet.

LENOIR, N.C. — Greer Labs, a developer and provider of allergy immunotherapy products and services, announced that the Food and Drug Administration has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass mixed pollens allergen extract) sublingual allergy immunotherapy tablet.

March 31, 2014

Just days after the Food and Drug Administration approved Otezla, a new oral therapy to treat active psoriatic arthritis in adult patients, Avella Specialty Pharmacy on Friday announced that it is prepared to begin distributing the drug.

PHOENIX — Just days after the Food and Drug Administration approved Otezla, a new oral therapy to treat active psoriatic arthritis in adult patients, Avella Specialty Pharmacy on Friday announced that it is prepared to begin distributing the drug. 

At this time, Avella is one of a select number of pharmacies that are contracted by Celgene, the drug manufacturer, to dispense the product at launch.

March 31, 2014

The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years.

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years. This is the first FDA approval of a drug for migraine prevention in this age group. 

The medication is taken on a daily basis to reduce the frequency of migraine headaches.

Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.

March 31, 2014

The Food and Drug Administration on Friday approved over-the-counter Nexium 24HR (esomeprazole 20mg), Pfizer announced.

NEW YORK — The Food and Drug Administration on Friday approved over-the-counter Nexium 24HR (esomeprazole 20mg), Pfizer announced. 

“Switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer,” stated Paul Sturman, president, Pfizer Consumer Healthcare. “The FDA approval of Nexium 24HR is a significant milestone in executing against our plan.”

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.