Generics

HYDERABAD, India and PRINCETON, N.J. — Dr. Reddy’s Laboratories on Friday announced the U.S. launch of its generic of AbbVie’s Prometrium (progesterone) capsules.

The Dr. Reddy’s progesterone capsules — recently approved by the Food and Drug Administration — will be available in 100- and 200-mg dosage strengths. According to QuintilesIMS data, brand and generic sales for the product had U.S. moving annual total sales of $153 million for the 12 months ended February 2017.

The capsules will be available in 100-count bottles.

LAKE ZURICH, Ill. and LAKE FOREST, Ill. — Fresenius Kabi will acquire Akorn, manufacturer and marketer of prescription and over-the-counter pharmaceutical products, for approximately $4.3 billion, or $34 a share, plus the assumption of approximately $450 million of debt. The transaction is expected to close by early 2018 and to be accretive in 2018 to Fresenius Group net income and EPS, excluding integration costs.

WASHINGTON — The Food and Drug Administration on Friday approved Renflexis (infliximab-abda) for multiple indications, the second FDA-approved biosimilar to Remicade. Renflexis is administered by intravenous infusion. Merck will market the drug, which will be developed by South Korea's Samsung Bioepis.

Remicade is manufactured by Johnson & Johnson.

PITTSBURGH — Mylan on Thursday today launched Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg and 16 mg in the United States. It is a generic version of the reference listed drug, Trilafon Tablets 2 mg, 4 mg, 8 mg and 16 mg, originally marketed by Schering.

Mylan previously received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for this product, which is used in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults.

JERUSALEM — Teva Pharmaceutical Industries on Thursday announced the simultaneous launch of AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/long-acting beta₂-adrenergic agonist (LABA) combination.

MAPLE GROVE, Minn. — Japanese generic pharmaceutical manufacturer Sawai Pharmaceutical will purchase the generic pharmaceuticals business of Upsher-Smith Laboratories, from its parent, Acova, for $1.05 billion.

Under Thursday’s agreement, expected to close near the end of June 2017, Rusty Field, the current President of Upsher-Smith, will continue leading the company. Following the closing, Upsher-Smith’s non-generic pharmaceuticals businesses will remain with Acova.

GUJARAT, India — Alembic Pharmaceuticals has received tentative approval from the Food and Drug Administration for its anti-depressive medication vilazodone hydrochloride, according to several published reports.

Tentative approval is given when a generic drug is ready for approval before the patent exclusivity for the reference product has ended. Final approval is delayed until that time.

SEOUL, South Korea — Daewoong Pharmaceutical on Wednesday announced it will launch its generic antibiotic Meroprenem in the United States. According to multiple reports, Meroprenem is not only Daewoong’s first product to be offered in the U.S., but also the first Korean generic drug sold in the U.S.

Meroprenem is a generic of Merem, developed by AstraZeneca, as a Carbapenem-series antibiotic widely used in hospitals to treat various ailments ranging from bacterial infections to general diseases.