Content about New Drugs & OTCs

February 15, 2013

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

JERUSALEM — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

February 14, 2013

Actavis can launch generic painkiller in May 2014 under settlement

Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

PARSIPPANY, N.J. — Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

The companies settled patent lawsuit regarding Actavis' generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32-mg strength. The companies settled litigation regarding the 8-mg, 12-mg and 16-mg strengths last month.

February 14, 2013

Eisai receives orphan drug designation for thyroid cancer drug

The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

The drug maker said Thursday that its experimental drug E7080 (lenvatinib) had received orphan drug designation from the FDA for follicular, medullary, anapestic and metastatic or locally advanced papillary thyroid cancer.

February 14, 2013

United Therapeutics resubmits application for pulmonary arterial hypertension drug

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

February 12, 2013

Galderma drug for common skin condition becomes available

A topical medication made by Galderma Labs for treating melasma of the face is now available in pharmacies, Galderma said.

FORT WORTH, Texas — A topical medication made by Galderma Labs for treating melasma of the face is now available in pharmacies, Galderma said.

Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%), tretinoin 0.05%) is described as the only Food and Drug Administration-approved triple combination topical product for the short-term treatment of moderate to severe melasma. The chronic skin condition affects more than 7 million people in the United States.

February 11, 2013

Agenda for upcoming 2013 Retail Clinician Education Congress now available

The agenda for the 2013 Retail Clinician Education Congress, which will be held in May in Las Vegas, is currently available, and those who register now can take advantage of a $99 registration fee.

LAS VEGAS — The agenda for the 2013 Retail Clinician Education Congress, which will be held in May in Las Vegas, is currently available, and those who register now can take advantage of a $99 registration fee.

To check out the 2013 RCEC agenda, click here.

The sixth annual RCEC conference, which is hosted by Drug Store News Group in conjunction with the Convenient Care Association, will be held May 14 to 16 at the Planet Hollywood Resort in Las Vegas.

February 11, 2013

Bartell Drugs introduces PharmaSmart kiosks

Bartell Drugs has introduced PharmaSmart blood pressure testing kiosks at all 58 of its stores, the regional retail pharmacy chain said Monday.

SEATTLE — Bartell Drugs has introduced PharmaSmart blood-pressure testing kiosks at all 58 of its stores, the regional retail pharmacy chain said Monday.

Bartell said it was the first drug store chain in the Pacific Northwest to provide the new kiosks, made by Rochester, N.Y.-based PharmaSmart International.

February 8, 2013

FDA approves generic diabetes drug

The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

SILVER SPRING, Md. - The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods' pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.

February 8, 2013

FDA approves Warner Chilcott ulcerative colitis drug

The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.

DUBLIN — The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.

Warner Chilcott announced the approval of mesalamine in the 400-mg strength.

The company plans to market the drug under the brand name Delzicol and launch it in March.

February 8, 2013

FDA gives tentative approval to Dr. Reddy's hypertension drug

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

February 8, 2013

Reports: Amgen plans six biosimilars

Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

NEW YORK — Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

February 6, 2013

FDA approves Elite Pharmaceuticals' opioid painkiller

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

February 6, 2013

FDA approves Sandoz antibiotic

The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval and launch of clindamycin in 5% dextrose in minibag form, the first generic version of Pfizer's Cleocin Phosphate in Dextrose 5%.

Sales of the branded version were $52.2 million in 2012, according to IMS Health.

February 5, 2013

Rx Timer Cap introduces easy-to-remove version

Rx Timer Cap has introduced a new version of the cap designed for ease of use among elderly patients.

LOS ANGELES — Rx Timer Cap has introduced a new version of the cap designed for ease of use among elderly patients.

The company announced Tuesday the introduction of the new EZ-Twist removal system for making the cap easy to open and close for people who don't require childproof caps.

February 5, 2013

WebMD launches allergy app

WebMD Health launched the WebMD Allergy app for the iPhone, a mobile resource that empowers consumers to take control of their allergies.

NEW YORK — WebMD Health Corp. on Tuesday launched the WebMD Allergy app for the iPhone, a mobile resource that empowers consumers to take control of their allergies.

"The WebMD Allergy app provides consumers with accurate and personalized weather-related allergy information to help them proactively manage their allergy conditions," stated Michael Smith, WebMD chief medical editor. "WebMD's trusted allergy information is delivered through an innovative mobile app to help consumers be better prepared to face the day."

February 4, 2013

Rexam, Rx Timer Cap partner to promote medication adherence

Prescription vial manufacturer Rexam has a deal with Rx Timer Cap to adapt the cap to its vials, Rexam said.

PERRYSBURG, Ohio — Prescription vial manufacturer Rexam has a deal with Rx Timer Cap to adapt the cap to its vials, Rexam said.

Rexam said the partnership would help improve medication adherence. The Rx Timer Cap has a built-in LCD timer that automatically counts the minutes and hours since patients last took their medication.

February 1, 2013

FDA approves new drug for potentially deadly ammonia conditions

The Food and Drug Administration has approved a new drug for treating some disorders that harm the body's ability to remove ammonia from the blood, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating some disorders that harm the body's ability to remove ammonia from the blood, the agency said Friday.

January 31, 2013

Supplement may reduce gestational diabetes risk in some women, study finds

A nutritional supplement may help ward off gestational diabetes in pregnant women, according to a new study.

NEW YORK — A nutritional supplement may help ward off gestational diabetes in pregnant women, according to a new study.

The study, conducted by researchers at Italy's University of Messina and published in the journal Diabetes Care, found that pregnant women with family histories of Type 2 diabetes who received myo-inositol saw a significant reduction in the incidence of gestational diabetes, a condition that causes high blood sugar in some pregnant women.

January 30, 2013

FDA approves Genzyme drug for rare cholesterol disorder

The Food and Drug Administration has approved a new drug for treating a rare cholesterol disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare cholesterol disorder, the agency said.

The FDA announced the approval of Kynamro (mipomersen sodium), made by Genzyme for the treatment of homozygous familial hypercholesterolemia, or HoFH. Kynamro has been approved as an orphan drug, a designation the FDA gives to drugs that treat diseases affecting fewer than 200,000 people.

January 30, 2013

FDA panel recommends approval for Boehringer Ingelheim COPD drug

A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.

RIDGEFIELD, Conn. — A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.

January 28, 2013

FDA accepts application for Genzyme MS drug

The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

CAMBRIDGE, Mass. — The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

Genzyme, a division of French drug maker Sanofi, said the FDA accepted its application seeking approval for Lemtrada (alemtuzumab) for relapsing MS. The company expects the agency to decide whether to approve the drug in the second half of this year.

January 28, 2013

FDA approves new use of Pfizer vaccine

The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

NEW YORK — The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

Pfizer announced the approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for children and adolescents ages 6 years to 17 years for active immunization against the 13 Streptococcus pneumonia serotypes the vaccine covers. For this group, Prevnar 13 is administered as a one-time dose to patients who have never received it.

January 28, 2013

FDA approves three new drugs for Type 2 diabetes

The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said Friday.

The FDA announced the approval of Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone) tablets.

Alogliptin is a new active ingredient, while metformin and pioglitazone are drugs already on the market.

January 25, 2013

Dr. Reddy's launches allergy drug

Dr. Reddy's has launched a drug used for treating allergies, the generic drug maker said Friday.

HYDERABAD, India — Dr. Reddy's Labs has launched a drug used for treating allergies, the generic drug maker said Friday.

The Indian drug maker announced the launch of desloratadine orally disintegrating tablets in the 2.5-mg and 5-mg strengths. The drug is a generic version of Merck's Clarinex Reditabs and is available in unit-dose packages of 30.

The branded version of the drug had sales of about $5.3 million during the 12-month period that ended in November 2012, according to IMS Health.

January 25, 2013

Merck: FDA approves Oxytrol for Women, creating overactive bladder category in OTC

Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area.

WHITEHOUSE STATION, N.J. — Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area. Most notable about this switch is the fact that the FDA approved Oxytrol for Women against the majority opinion of its Nonprescription Drug Advisory Committee, which voted five in favor and six opposed to the switch in November.