FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.
Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.
The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.
Federal court orders FDA to allow Watson diabetes drug launch; Mylan challenges ruling
PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.
Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda’s Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths. Mylan is challenging the decision.
Mylan, the world’s second-largest generic drug maker, filed a motion to stay the court’s order. “Mylan is disappointed in [the] ruling regarding pioglitazone, and we believe the court erred in its decision by directly contravening the Hatch-Waxman Act,” Mylan CEO Heather Bresch said, referring to the 1984 law that created an abbreviated approval pathway for generic pharmaceutical drugs.
“Mylan does not believe Watson is entitled to participate in Mylan’s 180-day exclusivity period in relation to this product, and we intend to pursue this case vigorously, including seeking expedited relief from the appellate court if necessary.” Watson filed suit against the FDA in August 2012, alleging that an agency decision to deny Watson’s claim to shared exclusivity in marketing a generic version of Actos would improperly delay its launch of the drug. Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health.
FDA approves generic Lupin
MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said on Oct. 18.
Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.
The drug is a generic version of Teva’s branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.
FDA approves Sandoz dermatology medication
PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.
Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval of desoximetasone ointment in the 0.25% strength. The drug is a generic version of Taro Pharmaceutical Industries’ Topicort and, according to Sandoz, is the first Fougera dermatology product Sandoz has launched since its $1.5 billion acquisition of the company in May 2012.
Topicort and its generic versions had sales of $36.5 million during the 12-month period that ended in August 2012, according to IMS Health.