Generics

PITTSBURGH A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions of an antidepressant drug.

 

Generic drug maker Mylan said Tuesday that it had obtained a temporary restraining order from the U.S. District Court for the District of New Jersey prohibiting Apotex from selling generic versions of the drug Paxil CR (paroxetine hydrochloride), an extended-release formulation of GlaxoSmithKline’s Paxil.

 

 

GLASGOW, Ky. Amneal Pharmaceuticals will have a grand opening of its newly expanded distribution and sales center next week, the generic drug maker said Monday.

 

Amneal announced the grand opening of the center in Glasgow, Ky., set to take place Monday. Representatives from the municipal and state governments, the Tennessee Valley Authority, state legislators and possibly members of Congress are expected to attend.

 

 

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.

 

Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.

 

 

WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.

 

The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.

 

 

According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”

WASHINGTON Generic drugs saved Medicare Part D beneficiaries and the program as a whole $33 billion in 2007, according to a new report by the nonpartisan Congressional Budget Office. The CBO expected another $14 billion in annual savings to accrue as many new generics enter the market through 2012.

 

The main lobby for pharmacy benefit managers said the report also showed the advantages of pharmacy benefit managers.

 

DETROIT Caraco Pharmaceutical Labs has appointed a new member to its board of directors.

 

The generic drug maker announced Wednesday the appointment of former KPMG accountant Eddie Munson to its board of directors.

 

 

Munson, who served in various positions for KPMG, will serve on Caraco’s board of directors for a term ending at the 2011 annual meeting of shareholders.

 

After a distinguished, eight-and-a-half-year tenure as chief of the National Community Pharmacists Association, Bruce Roberts, independent pharmacy’s toughest champion, retired June 25 as NCPA’s EVP and CEO. He now is president and CEO of Benecard Services, a small pharmacy benefit manager and prescription benefit facilitator firm founded by pharmacist Richard Ullman. Roberts, a longtime former independent pharmacy owner in Leesburg, Va., brought energy and passion to his role and helped spur a resurgence, both for the organization and independent pharmacy.