Content about Food and Drug Administration

January 24, 2014

Perrigo announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets.

DUBLIN — Perrigo Co. announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets — in 1-mg and 2-mg strengths. The company has started shipment of the drug. Perrigo previously launched the 0.5-mg strength in 2013.

January 22, 2014

The Food and Drug Administration launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.  

January 21, 2014

With the role of social media rapidly expanding, nearly half of pharmaceutical manufacturers are now actively using this channel to engage with patients on healthcare-related topics, according to a new report by the IMS Institute for Healthcare Informatics.

PARSIPPANY, N.J. — With the role of social media rapidly expanding, nearly half of pharmaceutical manufacturers are now actively using this channel to engage with patients on healthcare-related topics, according to a new report released Tuesday by the IMS Institute for Healthcare Informatics. 

January 21, 2014

The Consumer Healthcare Products Association responded to Sen. Charles Schumer’s, D-N.Y., recent call for the Food and Drug Administration and the Consumer Product Safety Commission to require flow restrictors on all bottles of children's liquid medicines.

WASHINGTON — The Consumer Healthcare Products Association on Monday responded to Sen. Charles Schumer’s, D-N.Y., recent call for the Food and Drug Administration and the Consumer Product Safety Commission to require flow restrictors on all bottles of children's liquid medicines.

January 21, 2014

Teva Pharmaceutical announced that it has entered into a definitive agreement under which Teva will acquire NuPathe for $3.65 per share in cash.

JERUSALEM — Teva Pharmaceutical on Tuesday announced that it has entered into a definitive agreement under which Teva will acquire NuPathe for $3.65 per share in cash, or approximately $144 million. In addition to the upfront cash payment, NuPathe shareholders will receive rights to receive additional cash payments of up to $3.15 per share if specified net sales of NuPathe's migraine treatment, Zecuity, are achieved over time.

January 21, 2014

Vivus and Auxilium Pharmaceuticals announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."

MOUNTAIN VIEW, Calif. — Vivus and Auxilium Pharmaceuticals on Tuesday announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." 

The PDUFA date for the supplemental filing is Sept. 20, 2014.

January 20, 2014

Bayer's Advantage Multi for Dogs (imidacloprid + moxidectin) received Food and Drug Administration approval as the first-ever treatment for circulating microfilaria in heartworm-positive dogs.

SHAWNEE, Kan. — Bayer's Advantage Multi for Dogs (imidacloprid + moxidectin) received Food and Drug Administration approval as the first-ever treatment for circulating microfilaria in heartworm-positive dogs. The approval was referenced in American Heartworm Society guidelines surrounding heartworm prevention and treatment.

January 20, 2014

The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week.

NEW YORK — The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week. 

Both Mekinist and Tafinlar are only available in limited distribution, and Onco360 is one of the few pharmacies with access to both medications.

January 17, 2014

The Consumer Healthcare Products Association responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

WASHINGTON — The Consumer Healthcare Products Association on Thursday responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.

WHITEHOUSE STATION, N.J. — Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack.

January 16, 2014

The Food and Drug Administration on Thursday issued a warning that some cryogenic wart removers — which remove warts from the skin by freezing them off — have caught fire during use at home, harming consumers or setting fire to items around the house.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued a warning that some cryogenic wart removers — which remove warts from the skin by freezing them off — have caught fire during use at home, harming consumers or setting fire to items around the house.

Since 2009, FDA has received 14 such reports about over-the-counter wart remover products. Ten patients have described singed hair, blisters, burns or skin redness, the agency stated.

January 16, 2014

The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

WASHINGTON — The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

January 15, 2014

A new drug for autoimmune diseases from Antares Pharma that the company calls the first of its kind is now available, the drug maker said Wednesday.

EWING, N.J. — A new drug for autoimmune diseases from Antares Pharma that the company calls the first of its kind is now available, the drug maker said Wednesday.

Antares announced the availability of Otrexup for rheumatoid arthritis and psoriasis in adults and polyarticular idiopathic arthritis in children. The company said the drug is the first Food and Drug Administration-approved subcutaneous methotrexate product for once-weekly self-administration. Otrexup, which the FDA approved in October, is available with a single-dose auto injector.

January 15, 2014

The Food and Drug Administration earlier this week issued final guidance for the industry on distinguishing liquid dietary supplements from beverages.

SILVER SPRING, Md. — The Food and Drug Administration earlier this week issued final guidance for the industry on distinguishing liquid dietary supplements from beverages. "We are issuing this guidance to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage," the agency stated.

January 15, 2014

The Food and Drug Administration recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit. 

January 13, 2014

The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

GURGAON, India — The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

Ranbaxy said it received a Form 483 from the FDA, a statement issued to a company's management after it has inspected a plant and found conditions that may violate the agency's regulations, and that products produced therein could be hazardous to people who use them. The plant in question is in Toansa, in India's Punjab region.

January 10, 2014

The Nonprescription Drugs Advisory Committee announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA.

SILVER SPRING, Md. — The Nonprescription Drugs Advisory Committee on Thursday announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 microgram (mcg)/actuation, as a temporary reliever of mild symptoms of intermittent asthma for consumers 12 years of age and older. 

January 10, 2014

The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can't be removed by surgery or has spread to other parts of the body, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can't be removed by surgery or has spread to other parts of the body, the agency said Friday.

The FDA announced the new approval for Mekinist (trametinib) and Tafinlar (dabrafenib). The agency originally approved the two drugs for use as single agents for the same indication in May 2013.

January 10, 2014

The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

DUBLIN — The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

Actavis announced the approval of telmisartan immediate-release tablets in the 20-mg, 40-mg and 80-mg strengths, which it intends to release immediately.

January 10, 2014

The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.

January 9, 2014

Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

PITTSBURGH — Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

The generic drug maker announced the launch of mycophenolic acid delayed-release tablets in the 180-mg and 360-mg strengths. The drug is a generic version of Novartis' Myfortic. As the first company to file a completed regulatory approval application for the generic, Mylan is entitled to 180 days in which to compete exclusively against Novartis' product before the Food and Drug Administration can approve additional generic versions.

January 8, 2014

Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA's approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.

January 8, 2014

News stories about doctor shopping and prescription pad pilfering in pursuit of a pain-pill induced high have become commonplace, prompting many legislators and regulators to consider further restrictions on pain medicines like hydrocodone compounds. But there may be a story that’s not being told — that the patients who suffer from chronic pain and need that hydrocodone to reclaim their lives are being stigmatized. The prevalence of pain pill abuse has left in its wake as many as 116 million legitimate pain sufferers who are finding it more difficult to access their therapies.

NEW YORK — News stories about doctor shopping and prescription pad pilfering in pursuit of a pain-pill induced high have become commonplace, prompting many legislators and regulators to consider further restrictions on pain medicines like hydrocodone compounds.

January 8, 2014

The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said Wednesday.

The FDA announced the approval of Farxiga (dapagliflozin) tablets, designed for use with exercise and dietary adjustments to control blood sugar. Type 2 diabetes affects about 24 million people in the United States, accounting for more than 90% of diabetes cases.

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn's disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.