Generics

SAN FRANCISCO — There may be a connection between taking vasodilators and developing early-stage, age-related macular degeneration, the leading cause of vision loss and blindness among Americans who are ages 65 and older, according to a study published online Wednesday in Ophthalmology, the journal of the American Academy of Ophthalmology.

PITTSBURGH — Mylan on Thursday announced that it has launched atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline's Malarone tablets. 

Mylan received final approval from the Food and Drug Administration for its abbreviated new drug application for this product, which is indicated to prevent Plasmodium falciparum malaria and the treatment of acute, uncomplicated P. falciparum malaria.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries posted a net sales increase of 13.2% to $759.3 million for its fiscal year ended March 31. Research and development expenses increased 19.2% to $55.4 million or 7.3% of net sales.

The Company recently received approval from the Food and Drug Administration for an abbreviated new drug application for phenytoin chewable tablets USP, 50 mg. During the quarter, the company filed three aNDAs with the FDA. 

With this, aNDAs representing 27 products await FDA approval, of which one is tentatively approved.

DUBLIN — Actavis on Tuesday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration seeking approval to market saxagliptin hydrochloride tablets, 2.5 mg and 5 mg.  

Actavis' ANDA product is a generic version of AstraZeneca and Bristol-Myers Squibb's Onglyza, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

HYDERABAD, India — Aurobindo Pharma on May 15 gained approval to produce a generic version of olanzapine orally disintegrating tablets in 5-mg, 10-mg, 15-mg and 20-mg strengths. The drug is the generic version of Zyprexa Zydis tablets from Eli Lilly.

The drug is used for the treatment of schizophrenia or bipolar I disorder. 

Olanzapine orally disintegrating tablets had U.S. sales of $120.8 million for the 12 months ended March 31, according to IMS Health.

SILVER SPRING, Md. — The Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The FDA and the U.S. Customs and Border Protection also conducted extensive examinations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the U.S., and found that most of the examined packages contained illegal prescription drugs that had been ordered from online sources.

CHICAGO — Despite clear evidence of ineffectiveness, guidelines and more than 15 years of educational efforts stating that the antibiotic prescribing rate for acute bronchitis should be zero, the rate was about 70% from 1996 to 2010 and increased during this time period, according to a study in the May 21 issue of JAMA.

JERSEY CITY, N.J. — Chirag Patel — co-CEO, chairman and co-founder of Amneal Pharmaceuticals — will be honored with the Alumnus of Distinction Award at New Jersey City University’s American Dream Gala on June 5.