규제 업데이트

Revolution Medicines' RAS inhibitor daraxonrasib, branded Rasonque, was approved by the FDA for metastatic pancreatic cancer after ASCO data earned a standing ovation.

The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.

FDA has approved ANDA 077783 for oral lamotrigine tablets (25‑200 mg) submitted by Chartwell Molecular, with multiple labeling submissions cleared.

The FDA has approved the ANDA 077491 for Pravastatin Sodium tablets from Amici Pharma, covering strengths from 10 mg to 80 mg.

FDA records show the oral tablet MEPROBAMATE (400 mg) is discontinued, with multiple manufacturing and labeling submissions approved between 1983 and 1999.

The FDA record shows Watson Labs' injectable Hydrocortisone Acetate (50 mg/mL) has been discontinued under ANDA085214.

DILOR-400, an oral tablet containing 400 mg theophylline, was approved under ANDA084751 with multiple manufacturing supplements; the product is currently discontinued.

Pharmacy societies watch the recent cabinet reshuffle, noting the nomination of a minister candidate for the Ministry of SMEs and Startups, which is involved in government talks on expanding telemedicine drug delivery.

The Korean MFDS will amend approval labeling for triptolide and azathioprine products, adding severe skin reaction warnings for triptolide and PRES and tremor warnings for azathioprine.

The FDA approved ANDA 076335 for the oral tablet TRI-PREVIFEM, containing ethinyl estradiol and norgestimate, sponsored by PH HEALTH. The product is listed as discontinued.

The FDA has approved ANDA077182 submitted by Dr. Reddys Labs SA for prescription oral tablets containing desogestrel and ethinyl estradiol, including multiple dosage strengths.

The FDA approved ANDA 084286 submitted by BARR for a 2 mg oral tablet of Triamcinolone. The product is listed as discontinued.