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.
Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the FDA approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer’s Genotropin.
Omnitrope originally received approval from the FDA for pediatric growth-related disorders in 2006 under a new drug application. Though Omnitrope technically is a follow-on biologic, no abbreviated approval pathway for follow-on biologics existed at the time.
The FDA approved a generic skeletal muscle relaxant made by Sagent Pharmaceuticals, Sagent said. The generic drug maker will offer orphenadrine citrate injection in 60 mg/2 mL, single-dose vials. Various versions of the drug had sales of about $4.3 million in 2011, according to IMS Health.
Amgen announced the FDA’s approval of the biotech drug Prolia (denosumab) for increasing bone mass in men and women who are at risk of fractures due to hormone ablation treatments they are receiving for prostate and breast cancer, respectively. “Bone loss and fractures are recognized adverse effects of hormone ablation therapies, but we have not had an approved treatment option to prevent these problems for our patients,” Massachusetts General Hospital Cancer Center genitourinary malignancies program head Matthew Smith said.
A drug made by Boehringer Ingelheim and Eli Lilly showed “meaningful and durable” reductions in blood sugar in adults with Type 2 diabetes, according to results of a late-stage clinical trial presented at a conference in Europe. BI and Lilly presented data from their 2,121-patient, 102-week phase-3 study of Tradjenta (linagliptin) at the European Association for the Study of Diabetes’ 47th annual meeting in Lisbon, Portugal, showing that the drug, combined with other drugs, lowered HbA1C levels by 0.8% over the long term.