Generics

Upsher-Smith parent Sawai

MAPLE GROVE, Minn. — Sawai Pharmaceuticals, the parent company of Upsher-Smith Laboratories, has announced a new strategic alliance with Japanese trading house Sumitomo. The alliance will see Sawai sell a 20% stake in its American subsidiary to Sumitomo’s U.S. arm for $211 million.

DANBURY, Conn., and RESEARCH TRIANGLE PARK, N.C. — Analytics company QuintilesIMS has a new name. Effective Nov. 6, the company will do business as IQVIA, with its name ticker symbol on the New York Stock Exchange set to switch to IQV on Nov. 15. The name change comes almost a year and a half after Quintiles merged with IMS Health in a $9 billion deal.

PITTSBURGH — Mylan has introduced its generic of Clolar (clofarabine 1 mg/ml) injection. The drug is indicated to treat patients ages 1 year to 21 years with relapsed or refractory acute lymphoblastic leukemia after at least two prior treatment regimens.

The latest launch adds to Mylan’s oncology portfolio, which it said contains more than 40 products. Mylan’s Clolar generic will be available in single-dose vials.

According to data from IQVIA (formerly QuintilesIMS), the drug had U.S. sales of $53 million for the 12 months ended Sept. 30.
 

GREENVILLE, N.C. — Mayne Pharma’s newest portfolio addition is its generic of Clorazil (clozapine) tablets. The antipsychotic is indicated to treat severely ill patients with schizophrenia and to reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.

“The launch of the full range of Clozapine tablets is our sixth product launch in 2017 and will further diversify our product offering,” Mayne Pharma CEO Scott Richards said.

MUMBAI — The Food and Drug Administration has approved Sun Pharma’s generic of Coreg CR (carvedilol phosphate) extended-release capsules. The drug is a beta blocker indicated to mild-to-sever chronic heart failure, left ventricular dysfuntion following myocardial infarction and hypertension.

Sun Pharma’s generic will be available in 10-, 20-, 40- and 80-mg dosage strengths. The product had U.S. sales of roughly $208 million for the 12 months ended August 2017, according to QuintilesIMS data. 

DUBLIN — Little more than a week after its first tentative approval for its 0.015% formulation of its Picato Gel generic, Perrigo has gained tentative approval from the Food and Drug Administration for a higher strength generic. The company’s ingenol mebutate, 0.05%, is indicated to treat actinic keratosis.

WASHINGTON — The Association for Accessible Medicines is filling out the ranks of its state government affairs team with experienced hands. The organization has brought on Brett Michelin as the team’s director and Ashlie Van Meter as senior director.

“We are excited to welcome Ashlie and Brett to the AAM team,” AAM vice president of state government affairs Carrie Hartgen said. “The depth and breadth of their experience in government affairs will be an asset to AAM's state affairs department.”