Generics

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.

The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.

Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.

The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.
 

Lupin has added to its generics lineup with its version of Valeant Pharmaceuticals’ Ancobon (flucytosine) capsules. The drug is indicated to treat serious infections caused by candida and/or Cryptococcus.

The product will be available from Lupin in 250- and 500-mg dosage strengths. These dosage strengths had U.S. sales of roughly $48 million for the 12 months ended October 2017, according to IQVIA data.

Perrigo on Monday announced the appointment of Uwe Röhrhoff as CEO, effective Jan. 15, following the retirement of John Hendrickson.

Generic maker Leading Pharma recently completed a financing transaction for $40 million of growth capital. The growth capital, led by Signet Healthcare Partners and Crestline Investors, will be used to expand the Fairfield, N.J.-based company’s pipeline and pay off debt.

Teva has re-launched its generic of Ritalin LA (methylphenidate hydrochloride) extended-release capsules. The drug is indicated to treat attention deficit hyperactivity disorder.

“The reintroduction of … is important to Teva’s generic portfolio,” Teva’s COO of North American generics, Maureen Cavanaugh, said. “We continue to be focused on bringing affordable generic treatment options to our customers.”