Content about Pharmaceutical industry

RARITAN, N.J. The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson for a drug to treat chronic pain, J&J said Monday.

PITTSBURGH Mylan has launched a generic version of a common antidepressant, the company said Friday.

Mylan announced the launch of bupropion hydrochloride extended-release tablets in the 150-mg and 300-mg strengths, a once-daily treatment for depression.

The drug is a generic version of GlaxoSmithKline’s Wellbutrin XL. Various versions of the drug had sales of around $752 million during the 12-month period ended in June, according to IMS Health.

MUMBAI, India The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Sun Pharmaceutical Industries.

Sun announced Wednesday the tentative approval of rosuvastatin calcium tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths.

JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.

Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.

Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.

DEERFIELD, Ill. Walgreens announced Thursday that Jeffrey Berkowitz, a former SVP at drug maker Merck, has joined the company.

Berkowitz will serve as Walgreens' SVP pharmaceutical development and market access, responsible for the overall pharmacy contracting strategy for the company, both on the pharmaceutical manufacturing side and on the retail payer side, the drug store chain said. He will report to Walgreens' pharmacy services president Kermit Crawford.

CHADDS FORD, Pa. Endo Pharmaceuticals will acquire generic drug maker Qualitest Pharmaceuticals for $1.2 billion, Endo said Tuesday.

Endo said the purchase of privately owned Qualitest would expand its offering of branded drugs, generics, devices and services in areas such as pain and urology. Qualitest is the sixth largest generic drug company in the United States, as measured by prescriptions filled.

NEW YORK The Hart-Scott-Rodino waiting period for Bristol-Myers Squibb’s acquisition of Seattle-based biotech company ZymoGenetics has expired, enabling Bristol’s acquisition to go through, the drug maker said Tuesday.

The drug maker announced the deal to acquire ZymoGenetics for $885 million, or $9.75 per share, earlier this month.

Like a freighter in the Atlantic Ocean during hurricane season, anyone with a stake in the generic drug industry will encounter smooth and bumpy sailing alike over the next few years, according to a recent presentation by an industry expert.

Many generic drug companies have long marketed branded drugs on the side, but lately, some branded drug companies have sought to enter the generics business as well. One of those companies is Meda Pharmaceuticals, the U.S. subsidiary of Swedish drug maker Meda AB. Drug Store News recently interviewed John White, Meda’s senior director of marketing.

Drug Store News: What gave Meda the idea of pursuing generics?

ARDEE, Ireland Drug maker Warner Chilcott will buy the U.S. rights to a treatment for overactive bladder for $400 million, the company said Friday.

The drug maker announced that it would terminate its co-promotion agreement with Novartis concerning the drug Enablex (darifenacin) and purchase the rights to sell it in the United States. It may be required to make additional milestone payments of up to $20 million to Novartis.