Regulatorische Updates

The FDA granted approval for SUN PHARM INDUSTRIES' ANDA080699 covering oral Meprobamate tablets (200 mg and 400 mg). Multiple manufacturing and labeling submissions were approved between 1986 and 1998; the products are now discontinued.

The FDA approved ANDA080094 for the oral tablet TRIPLE SULFOID, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, though the product is listed as discontinued.

The FDA has approved ANDA078965 for a prescription oral tablet combining norethindrone, ethinyl estradiol, and ferrous fumarate, submitted by BARR.

The FDA has initiated recall D-0296-2023 because the affected product failed to meet sterility assurance requirements.

The FTC says Aurobindo must sell four drugs to address antitrust concerns before finalizing its $250 million acquisition of Lannett.

A new patient alert card warns men on finasteride of psychiatric side effects and persistent sexual dysfunction.

The MHRA released a summary of letters and notifications sent to healthcare professionals in April 2024 regarding medicines, medical devices, and two new Device Safety Information pages.

MHRA notes topical steroids are effective but carry serious risks, especially with long‑term high‑potency use, and will update labelling soon.

FDA approved ANDA087274 for two hydroxyzine hydrochloride injectable products from Watson Labs; both are now listed as discontinued.

FDA approved application ANDA086746 for an oral amitriptyline hydrochloride 25 mg tablet submitted by Lederle; the product is listed as discontinued.

The FDA lists ANDA 086095 for Watson Labs' chlorpheniramine maleate injectable (100 mg/mL). The product is marked discontinued.

The FDA has issued a recall for products with labeling errors, specifically incorrect or missing lot numbers and expiration dates that exceed the Beyond Use Date of at least one ingredient.