Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.
U.S. generic drug maker Watson Pharmaceuticals and Indian drug maker Natco Pharma will work together to develop and commercialize a generic drug used for bone marrow disorders, the two companies said. The agreement concerns lenalidomide tablets in the 5-mg, 10-mg, 15-mg and 25-mg strengths. The drug is a generic version of Celgene’s Revlimid, used to treat the plasma cell cancer multiple myeloma and myelodysplastic syndrome.
T he FDA has approved Sagent Pharmaceuticals’ topotecan hydrochloride for injection, a generic version of GlaxoSmithKline’s chemotherapy drug Hycamtin, Sagent said. The U.S. market for injectable topotecan was around $158 million in 2010, according to IMS Health. Topotecan is used in patients who have recurrent small-cell lung cancer sensitive disease or cervical cancer.
An FDA advisory committee has recommended approval for an investigational diet pill. Orexigen Therapeutics and Takeda Pharmaceutical announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.
In the past, the agency declined to approve such diet pills as Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin), while requesting that Abbott’s Meridia (sibutramine) be removed from the market due to safety concerns.
Johnson & Johnson made its courtship with Dutch biotech company Crucell official by acquiring all of the company for $2.3 billion, the two companies said.
J&J said it would maintain Crucell’s headquarters in Leiden, Netherlands, and keep it as the center for vaccines within J&J’s pharmaceuticals division. It also would keep the company’s senior management and “generally” keep its current staff intact.