규제 업데이트

FDA approves Sevelamer Carbonate oral suspension (ANDA207291), a prescription product available in 800 mg and 2.4 g packets, sponsored by Macleods Pharms.

Pergoberis® Pen, an infertility treatment, will be reimbursed under Korea’s health insurance from Sep 1, covering all three dosage strengths.

The FDA approved ANDA206918 for Fondaparinux Sodium subcutaneous solutions, manufactured by Eugia Pharma, with multiple dosage strengths and NDC codes.

CYLERT, an oral chewable tablet with 37.5 mg PEMOLINE, is listed as discontinued. The FDA record shows a series of labeling, manufacturing and priority submissions from 1976 to 2005.

FDA granted approval for Hikma's deferoxamine mesylate injectable products (ANDA078086), available in 500 mg and 2 g vials, both listed as discontinued.

FDA approved ANDA077784 for multiple oral risperidone tablet strengths submitted by Ratipharm; all listed products are marked discontinued.

The FDA has granted approval for Ohm Laboratories’ generic Valsartan tablets (40‑320 mg) under application ANDA 077492.

The FDA has granted approval for ANDA077183, a prescription oral capsule combining amlodipine besylate and benazepril hydrochloride, manufactured by Dr. Reddy's Laboratories.

The Ministry of Health and Welfare issued a notice on Aug 26 prohibiting the creation of private qualifications that use titles such as “pharmacist,” “herbal pharmacist,” “pharmacy coordinator,” or “pharmacy administrator,” to prevent public confusion.

The FDA has granted approval for Chartwell RX’s levofloxacin tablets in 250 mg, 500 mg and 750 mg oral strengths under ANDA 076890.

The FDA has approved application ANDA076336 for MirtaZAPINE oral tablets in 15 mg, 30 mg, and 45 mg strengths, submitted by Actavis Labs FL Inc.

The FDA approved ANDA076609 for a 100 mg propoxyphene napyslate and 650 mg acetaminophen oral tablet submitted by Watson Labs Florida; the product is listed as discontinued.