Generics

PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.

MORRISTOWN, N.J. — Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

Watson, through subsidiary Watson Labs, said it applied for approval of a generic version of Daiichi Sankyo’s and Genzyme’s Welchol (colesevelam hydrochloride). The drug, a powdered oral suspension, is used to reduce “bad” LDL cholesterol in patients with primary hyperlipidemia, either alone or in combination with a statin.

JERUSALEM — Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

Teva and APP launched gemcitabine hydrochloride injfection in 200-mg and 1-g single-dose vials. The drug is a version of Eli Lilly’s Gemzar, which had sales of about $785 million in the United States in 2010, according to IMS Health. The drug is used to treat cancers of the lungs, pancreas, breasts and ovaries.

WASHINGTON — More than 55,000 candidates sat for the Pharmacy Technician Certification Exam in 2010, the Pharmacy Technician Certification Board said Tuesday.

The PTCB said it has certified more than 400,000 pharmacy technicians since 1995.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

PITTSBURGH — Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

Mylan announced Tuesday that it had settled patent litigation suits with Pfizer concerning Lipitor (atorvastatin calcium) and Caduet (atorvastatin calcium and amlodipine besylate).

Under the Caduet agreement, the lawsuit will be dismissed, and Mylan can launch its generic version on Nov. 30. Terms of the Lipitor agreement remain confidential.

PITTSBURGH — The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

The FDA approved Matrix Labs’ pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths.

The drug is a version of Protonix DR, made by Wyeth, now part of Pfizer. Various versions of the drug had sales of around $1.7 billion during the 12-month period ended in September, according to IMS Health. The FDA also approved a version made by Dr. Reddy’s Labs on Friday.

HYDERABAD, India — Indian drug maker Dr. Reddy’s Labs has launched a generic treatment for gastroesophageal reflux disease.

The company announced Thursday the launch of pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is a version of Protonix, made by Wyeth, now part of Pfizer.

Pantoprazole sodium delayed-release tablets had sales of around $1.8 billion during the 12-month period ended in September 2010, according to IMS Health.