Endothelin Receptor Antagonist REMS Information

by Pill Pals Customer Service | Jul 7, 2025 | News

Based on a new analysis of human pregnancy data compiled from the use of endothelin receptor antagonist (ERA) medicines for two decades, FDA has determined that risk evaluation and mitigation strategy (REMS) requirements related to embryofetal toxicity (EFT) risk are...

Verify Wholesale Drug Distributor Licenses

by Pill Pals Customer Service | Jul 7, 2025 | News

Valid License is Required Under the LawPrescription drugs should only be purchased from wholesale drug distributors with a valid license in the U.S. and who are authorized by law. Unlicensed and unauthorized trading partners put patients at risk of taking unsafe,...

Exela Pharma Sciences, LLC – 709859

by Pill Pals Customer Service | Jul 3, 2025 | News

Delivery Method: Via Email Reference #: 320-25-88 Product: Drugs Recipient: Recipient Name Phanesh Koneru, PhD, LL.M. Recipient Title President and CEO Exela Pharma Sciences, LLC 1245 Blowing Rock BlvdLenoir, NC 28645-3618United States Issuing Office: Center for Drug...

FDA grants accelerated approval to sunvozertinib for metastatic non-sm

by Pill Pals Customer Service | Jul 2, 2025 | News

On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor...

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

by Pill Pals Customer Service | Jul 2, 2025 | News

The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. The FDA updates this...