FDA grants orphan drug designation to Biodel drug for rare insulin disease
DANBURY, Conn. — The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.
Biodel announced that it had received orphan drug designation for glucagon to prevent hypoglycemia, or abnormally low blood sugar, in patients with CHI.
The FDA grants orphan drug designation to treatments for rare diseases. The designation makes the companies receiving it eligible for incentives like FDA grant-funding for clinical trial costs, tax credits, waiver of user fees and a seven-year period of marketing exclusivity following regulatory approval, compared with the five that new drugs normally receive.
CHI occurs in 1-in-30,000 to 50,000 births, and children who have it generally need aggressive artificial calorie support to prevent hypoglycemia and neurologic damage, but neurologic damage still occurs in about 20% to 50% of cases.
No comments found
Par distributes authorized generic of AstraZeneca hypertension drug
WOODCLIFF LAKE, N.J. — Par Pharmaceutical Cos. has contracted with AstraZeneca to distribute an authorized generic version of a drug used to treat high blood pressure, Par said.
Par announced that it had entered a supply and distribution agreement through subsidiary Par Pharmaceutical to distribute an authorized generic version of Atacand HCT (i.e., candesartan cilexetil and hydrochlorothiazide) tablets.
An authorized generic is a branded drug marketed under its generic name at a discounted price, usually through a third-party company.
Par has started shipping the drug in the 16/12.5-mg, 32/12.5-mg and 32/25-mg strengths. Atacand HCT has annual sales of aboutt $61 million, according to IMS Health.
No comments found
J&J subsidiary seeks new approval for psoriasis drug
HORSHAM, Pa. — Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat active psoriatic arthritis, the company said Thursday.
J&J subsidiary Janssen Biotech submitted an application to the FDA for Stelara (ustekinumab) for adult patients with the disease, which affects more than 2 million people in the United States, according to the National Psoriasis Foundation. Another subsidiary is seeking approval for Stelara for the same usage in Europe.
"We are pleased to present applications to health authorities in the U.S. and Europe seeking approval of Stelara for the treatment of active psoriatic arthritis, a chronic, debilitating immune-mediated inflammatory diseases," Janssen Research and Development VP and head of immunology development Jerome Boscia said.
The drug is already approved for treating moderate to severe plaque psoriasis in adults.
How can I recive stelara and what about the price and doses please