FDA OKs Levemir for pregnant women
NEW YORK — A diabetes treatment made by Novo Nordisk is safe for pregnant women, according to a recent decision by the Food and Drug Administration.
Novo Nordisk said Monday the FDA had approved Levemir (insulin detemir [rDNA origin]) for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to fetuses. The agency’s decision was based on results of a clinical trial involving 310 women that compared Levemir to another insulin product.
The insulin is used to treat Type 1 and Type 2 diabetes.
Was the trial done on pregnant women as well? Wouldn't that pose a considerable risk to the mother and child? For an untested drug that could potentially harm the fetus, were the mothers involved in the trial aware of the risks?
NACDS, NCPA renew merger opposition with new court filing seeking immediate relief
ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Monday afternoon announced their intent to file an additional motion requesting that the judge direct Express Scripts and Medco to keep separate their assets pending review of the lawsuit and/or schedule an expedited review of the merits of a case the two associations filed in district court last week.
“We continue to believe that the compelling arguments and evidence brought to the [Federal Trade Commission] by NACDS, NCPA, consumer groups and others warrant blocking this merger," both NACDS and NCPA released in a joint statement. "That the agency is allowing the merger to proceed, and without any conditions, leaves patients and pharmacies vulnerable to significant harm from a combined ESI-Medco. Furthermore, we are disappointed that the agency based some of its views of the PBM-pharmacy marketplace on old, inaccurate data, despite NACDS and NCPA providing evidence to the contrary."
NACDS and NCPA, along with nine community pharmacy complainants, last week filed a suit challenging the then-proposed Express Scripts/Medco merger in anticipation of an imminent approval. Both Express Scripts and Medco were served summonses regarding that suit earlier Monday morning, according to court documents.
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Teva launches generic hypertension drugs
JERUSALEM — Teva Pharmaceutical Industries has launched generic versions of two blood pressure drugs made by Sanofi, Teva said Monday.
Teva announced the launch of irbesartan and irbesartan/hydrochlorothiazide tablets, respectively generic versions of Avapro and Avalide. Avapro has annual sales of $464 million, and Avalide has annual sales of $124 million, according to IMS Health. Both drugs are used to treat high blood pressure, also known as hypertension.
Teva was the first company to file for and win approval for generic versions of the drug, entitling it to 180 days of market exclusivity in which to compete directly with Sanofi’s products.
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