Product news from the 02/20/07 News Brief

Share this article:
Mylan Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for propranolol hydrochloride extended-release (ER) capsules in 60mg, 80mg, 120mg and 160mg strengths. Propranolol hydrochloride ER capsules are the generic version of Wyeth’s beta blocker, Inderal LA, which had US sales of approximately $201 million for the same strengths for the 12-month period ended Dec. 31, 2006, according to IMS Health. The FDA has granted priority review status to Gilead Science’s hypertension drug ambrisentan on a priority basis. Ambrisentan is a potential treatment for pulmonary arterial hypertension, a type of high blood pressure that affects the lungs and leads to heart failure. Priority FDA review typically takes six months, only half as long as the one year a drug is typically under review.
Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Payment database confounds doctors

ProPublica reports that doctors are struggling with a time-intensive registration process and are getting an error message that CMS says is not an error message.

Gilead's idelalisib hat trick

The FDA greenlighted the drug for three cancers.

Shire expands rare disease reach

A $225-million deal with US biotech ArmaGen gives Shire worldwide commercialization rights to an experimental enzyme replacement therapy.