FDA approves lower dose of Bayer’s Angeliq
WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.
Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.
"We are pleased by the approval of this important new lower-dose option for menopausal women," Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. "The availability of the new lower dose of Angeliq supports current guidelines which recommend that treatment with hormone therapy should aim to use the lowest effective dose."
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PBM drug diversion ad ‘a new low?’
Are pharmacists the weak link in the drug diversion chain? That’s what the pharmacy benefit management lobby seems to imply in a new and controversial ad campaign that questions whether community pharmacists are doing all they should to halt the illegal flow of narcotics from the legitimate pharmaceutical supply chain to the dealer on the street.
The Pharmaceutical Care Management Association launched its latest salvo against retail pharmacy last week on behalf of pharmacy benefit management firms, riding a wave of heightened alarm in Congress over the abuse of prescription drugs. On Thursday, PCMA debuted a new ad and position statement on prescription drug abuse and diversion as the U.S. House of Representatives Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade held a hearing, “Prescription Drug Diversion: Combating the Scourge.”
The problem is real enough: According to the Centers for Disease Control and Prevention, prescription drug abuse has reached the stage of a national epidemic that kills nearly as many people as car accidents. But by charging in its ad that “drug diversion may start at the local pharmacy counter” and charging that “the drug store lobby” is “trying to limit pharmacy fraud and abuse enforcement,” among other accusations, PCMA seems to be calling into question the motives and commitment of retail pharmacists in the fight to control drug diversion.
It’s a breathtaking charge. Instead of enlisting the community pharmacies they depend on to fill out their provider networks in a coordinated campaign to seal up the drug-diversion pipeline, the PBMs represented by PCMA are ratcheting up their long-simmering feud with community pharmacists by stopping just short of accusing them of being part of the problem. What’s more, the charge comes in the wake of a series of deadly crimes against community pharmacies by violent criminals willing to kill both pharmacy staff and drug store customers in their quest to steal controlled substances. That makes the latest salvo by PCMA not only breathtaking; it’s cynical, irresponsible and way off the mark.
The independent pharmacy group National Community Pharmacists Association calls the PBM action “a new low.” Let us know if you agree by commenting below.
The huge increase in prescription narcotic abuse is occurring because of the huge push to treat pain. The issue started with JCAHO and has spread to the legal community. Providers treat pain with drugs that in the past would have never been used. This has resulted in people getting narcotics that in the past would never have happened. If congress wants to put the lid on this practice a bit of tort claim reform would help. So would the curtailing of JCAHO's standards.
Dr. Reddy’s launches generic version of Pfizer’s Geodon
HYDERABAD, India — Indian drug maker Dr. Reddy’s has launched a drug designed to treat bipolar disorder and schizophrenia, the company said.
The company announced the launch of ziprasidone hydrochloride capsules in the 20-mg, 40-mg, 60-mg and 80-mg strengths.
The drug is a generic version of Pfizer’s Geodon, which had sales of $1.34 billion in 2011, according to IMS Health.
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