Mylan launches generic hypertension drug
PITTSBURGH — The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.
Mylan announced the approval and launch of candesartan cilexetil and hydrochlorothiazide tablets in the 16/12.5-mg, 32/12.5-mg and 32/25-mg strengths. Mylan said it was the first company to submit a complete regulatory approval application for the drug and is thus entitled to 180 days of market exclusivity in which to compete directly with the branded version.
The drug is a generic version of AstraZeneca’s Atacand HCT, which had sales of $56.3 million during the 12-month period ending in September, according to IMS Health.
Walgreens and Cystic Fibrosis Foundation share joint ownership of specialty pharmacy
DEERFIELD, Ill. — Walgreens and the Cystic Fibrosis Foundation on Friday announced they have completed a transaction giving Walgreens a significant ownership stake in Cystic Fibrosis Foundation Pharmacy, the parent company of Cystic Fibrosis Services.
Terms of the agreement were not disclosed.
The transaction gives Walgreens and the CF Foundation joint ownership of two businesses: CF Services, a specialty pharmacy for cystic fibrosis patients and their families; and Pharma Dynamics, a provider of new product launch support and call center services for drug manufacturers. CF Services will continue to operate under its current name and remain based in the same location in Bethesda, Md. Pharma Dynamics was previously CF Services’ Corporate Accounts Division.
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.