Generics

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic from Taiwan-based drug development company Sunny Pharmtech and generic development company Vitruvias Therapeutics. The companies announced the approval of its generic lidocaine ointment, 5%.

SILVER SPRING, Md. — Lupin is adding to its topical generics portfolio. The Food and Drug Administration has approved Lupin’s generic of Galderma Laboratories’ Clobex (clobetasol propionate, 0.05%) lotion, the company announced Tuesday.

The product is indicated to relieve various corticosteroid-responsive dermatoses in patients ages 18 years and older. For the 12 months ended June 2017, the drug had U.S. sales of $14.3 million, according to QuinitlesIMS data.

JERUSALEM — Teva is reintroducing its generic of Depo-Provera (medroxyprogesterone acetate injectable suspension, 150 mg/mL) contraceptive injection. The drug is indicated to prevent pregnancy.

SILVER SPRING, Md. — Perrigo is adding to its portfolio of opioid generics. The Food and Drug Administration has approved the company’s generic of Exalgo (hydromorphone HCL, 32 mg) extended-release tablets.

The drug is an opioid indicated to manage moderate to severe pain in patients requiring continuous around-the-clock pain opioid analgesia for an extended period of time. Perrigo said it planned to make the generic available by the end of September.

WASHINGTON — A new report from the Moran Co. for the Association for Accessible Medicines and its Biosimilars Council is projecting big savings to the federal government from biosimilars in the next 10 years. But the estimated $11.4 billion in savings would require the Centers for Medicare and Medicaid Services to revise the way it currently reimburses for biosimilar drugs.

MUMBAI — Lupin is looking to a longtime pharmaceutical industry veteran to head its business development and global mergers and acquisitions functions. The company named Jim Loerop its chief corporate development officer Monday, charging him with integrating its business development, licensing and M&A teams to drive its business strategy.

SILVER SPRING, Md. — Perrigo has received tentative approval from the Food and Drug Administration for its generic of Acanya (clindamycin phosphate, 1.2%, and benzoyl peroxide, 2.5%), the company announced Monday. Perrigo has previously settled litigation with Valeant Pharmaceuticals North America and Dow Pharmaceuticals concerning the product.

The drug is indicated to treat acne vulgaris in patients ages 12 years and older. It had U.S. sales of roughly $57 million for the 12 months ended July 2017, Perrigo said.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first biosimilar approved to treat cancer, Amgen’s Mvasi (bevacizumab-awwb), a biosimilar of Avastin.