News

FDA approves Mylan’s Precedex generic

BY David Salazar

PITTSBURGH — The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. The intravenous sedative is a generic version of Precedex, which is manufactured by Hospira. 

“Mylan's launch of a therapeutically equivalent version of Precedex Injection … represents an important addition to Mylan's injectables portfolio and growing line of products in the anesthesia and pain management category,” Mylan CEO Heather Bresch said. “As we continue to bring a high-quality, reliable supply of injectable products to the U.S. market, Mylan looks forward to delivering on its promise of providing quality medicine and service excellence in the increasingly important institutional space."

The company began shipping the single-dose vials immediately. According to IMS Health, the injection’s sales were at about $156 million by the end of June. Mylan currently has almost 300 Abbreviated New Drug Applications before the FDA for generic products. 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
News

DripDrop expands distribution

BY Michael Johnsen

SAN FRANCISCO — DripDrop, a medical-grade hydration solution, is now available at Walgreens stores nationwide and on Walgreens.com, the company announced Tuesday. 
 
"Walgreens pharmacists were big believers in DripDrop from the very beginning, when we were working out of my clinic in San Francisco and the pharmacist downstairs began recommending it to her patients," said Eduardo Dolhun, founder and chief medical officer of DripDrop. "Three-quarters of Americans suffer from some form of dehydration on a daily basis, and its impact on health and wellbeing is far-reaching. With DripDrop now available at Walgreens, consumers can treat dehydration at home, possibly avoiding an unexpected visit to the doctor or hospital for IV therapy."
 
Dolhun developed DripDrop after he witnessed the efficacy of oral rehydration solutions during humanitarian efforts abroad. Before DripDrop, medical grade hydration solutions either tasted terrible or required intravenous delivery. DripDrop's precise ratio of ingredients meets the international health community's standards to treat and prevent dehydration, while maintaining a taste profile similar to a sports drink. It has 25% more electrolytes than pediatric alternatives, and no artificial colors, flavors or preservatives.
 
Safe to drink at home everyday and powerful enough to treat dehydration in a hospital setting, DripDrop comes in powdered packets that are mixed with water. Each box of DripDrop contains eight packets; each packet makes an 8-oz. serving. DripDrop retails for $9.99.
 
keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
News

Survey: Half of women experiencing OAB report current treatment option not working

BY Michael Johnsen

IRVINE, Calif. — Nearly half of women age 45 years or older who experience symptoms of overactive bladder report their current treatment does not address their OAB symptoms, according to a recent survey conducted by The Harris Poll on behalf of Allergan.
 
Nearly 9-in-10 women surveyed report that OAB impacts their everyday life, and about 2-in-3 women have used some kind of treatment to manage their OAB symptoms, most commonly pills prescribed by a physician (31%). Despite the impact of the condition, about 21% worry about being perceived as a difficult patient if they are unhappy with a treatment plan.
 
Treatment often begins with such lifestyle changes as reduction of fluid intake, decreased amounts of caffeine, bladder-control strategies and pelvic floor muscle training. Anticholinergic medications, in the form of pills, also are often prescribed by physicians to manage OAB. In one study of 1,117 patients, the majority of patients (73.5%) stopped taking their pills within one year due to side effects and/or lack of results. 
 
An estimated 39 million Americans currently are living with OAB — a common, sometimes disabling, condition often associated with a considerable impact on patients with symptoms that include a strong, sudden need to urinate and urinary frequency with or without leakage.
 
In May, the American Urological Association released updated treatment guidelines for OAB, Allergan stated, which supports Allergan's Botox as an appropriate therapy to consider for the treatment of overactive bladder when self-management is not effective, and anticholinergic medications do not work well enough or are too difficult to tolerate. Botox works by calming the nerves that trigger the overactive bladder muscle, helping to reduce daily leakage episodes, treat the strong need to urinate right away and reduce the number of times needed to empty the bladder daily.
keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?