Generics

MANCHESTER, N.H. — Boston Therapeutics is seeking approval for a generic version of a pill for Type 2 diabetes, the drug maker said.

Boston Therapeutics announced that it had filed an application with the Food and Drug Administration for chewable metformin tablets. The drug is a version of Bristol-Myers Squibb's Glucophage.

SILVER SPRING, Md. — The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

The new organizational scheme will add a new division to the bioequivalence program called Division of Bioequivalence II and a new chemistry division, Division of Chemistry IV.

NEW YORK — The world's top-selling drug may become available over the counter, if its manufacturer has its way, according to published reports.

The New York Times reported that Pfizer may be looking for Food and Drug Administration approval for an OTC switch for Lipitor (atorvastatin calcium), a cholesterol-lowering medication. The Times quoted an unnamed source as providing the information, though Pfizer declined to comment.

PHILADELPHIA — A generic pharmaceutical company announced that its CFO has resigned.

Lannett said that Keith Ruck has exited the company to pursue other interests. The company expects to name a successor soon.

“During his tenure, Keith improved the performance of our accounting and financial reporting team,” Lannett president and CEO Arthur Bedrosian said. “In addition, he was instrumental in upgrading our internal controls and business processes. I would like to thank Keith for his hard work and wish him well in his future endeavors.”

MUMBAI, India — Indian generic drug maker Wockhardt will sell its nutrition business to France's Danone, the company said Tuesday.

The deal is worth $355 million, according to published reports, and includes brands like Farex, Dexolac, Nusobee and Protinex.

Wockhardt said the deal was part of a strategy to consolidate and rationalize its core operations and focus on its pharmaceutical business.

SKOKIE, Ill. — Topco, a member-owned cooperative serving the food industry, recently kicked off an initiative substituting its TopCare-branded over-the-counter medicines for the equivalent prescription pharmaceutical, where appropriate, in an effort to save patient dollars and promote the TopCare brand.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical had sales of $224.2 million and profits of $9.05 million during second quarter 2011, the drug maker said Wednesday.

These compared with respective sales and second-quarter profits of $255.5 million and $18.4 million in second quarter 2010.

For the first six months of fiscal year 2011, the company had sales of $435.8 million and a loss of $99.9 million, compared with $537 million in sales and profits of $44.7 million during the first six months of 2010.

 

ST. LOUIS — The Food and Drug Administration has approved an opioid painkiller made by Covidien's generic drug division, the medical supply company said.

Covidien said the FDA approved Mallinckrodt's morphine sulfate oral solution, used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients.