Generics

SUPPLIER NEWS — The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths. Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.


AUSTIN, Texas — The Food and Drug Administration has approved a new strength for a psychiatric drug made by Edgemont Pharmaceuticals, Edgemont said Tuesday.

The drug maker announced the approval of a 60 mg dose of fluoxetine tablets, a treatment for major depressive disorder, obsessive compulsive disorder, bulimia nervosa and panic disorder. The drug was originally marketed under the brand name Prozac.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Tuesday released results from a survey of more than 800 independent community pharmacists about the negative consequences for their patients and their businesses if diabetes testing supplies under Medicare Part B are subjected to competitive bidding prices.

“The message from our survey is clear: applying competitive bidding prices for diabetes testing supplies to independent community pharmacies is financially unsustainable for these pharmacies,” stated NCPA EVP and CEO Douglas Hoey.

WASHINGTON — Drug makers have 901 biotech drugs under development for more than 100 diseases ranging from cancers and infectious diseases to autoimmune disorders and cardiovascular diseases, the Pharmaceutical Research and Manufacturers of America said.


HIGH POINT, N.C. — The Food and Drug Administration has accepted the first regulatory approval application for a generic version of a cancer drug made by Eisai.

Banner Pharmacaps announced Tuesday that it had filed for regulatory approval of generic bexarotene gelatin capsules in the 75-mg strength, a generic version of Eisai's Targretin, used to treat cutaneous T-cell lymphoma, or CTCL skin cancer. Under the Hatch-Waxman Act of 1984, once the drug is approved, Banner will be the exclusive supplier of a generic version of Targretin for 180 days.

A group representing independent pharmacies is urging Congress to cut the deficit by reducing healthcare expenditures, but “without compromising patients’ access to their pharmacy of choice or harming local jobs.” In a letter sent last month to the Joint Select Committee on Deficit Reduction, the National Community Pharmacists Association suggested increasing use of generic drugs, encouraging such services as medication therapy management, collecting manufacturer rebates, and allowing patients to choose their pharmacies and avoid requirements to use mail-order services.

NEW YORK — Drug maker Warner Chilcott's diversified portfolio of drugs will help it weather generic challenges to its patents, according to a new report by Zacks Investment Research.

JERUSALEM — The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

Before it can complete the $6.8 billion deal, Teva must sell to Par Pharmaceutical Cos. its generic versions of two Cephalon drugs, namely generic versions of the cancer pain drug Actiq (fentanyl citrate) and the muscle relaxant drug Amrix (cyclobenzaprine), which have combined sales of $298 million per year, according to IMS Health.