USFDA

The U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death.

Indoco Remedies Ltd. announces final approval from the United States Food and Drug Administration (USFDA) for Lacosamide Tablets USP 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets of UCB, Inc.

Lacosamide Tablets are indicated for the prevention and control of seizures. It is an anticonvulsant / antiepileptic drug.

Granules India Limited, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, located in Chantilly, Virginia, USA received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA).

The GPI facility was inspected by the US FDA from 24th to 28th January 2022 for two of its product applications filed. There were three minor observations during the inspection and GPI had addressed the observations in the stipulated time period.

Zydus Lifesciences Ltd has received final approval from the USFDA to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid). Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet.

Colestipol Hydrochloride is a highly complex macro molecule drug substance with little or no systemic absorption.

The SMILE-100 System is a breast thermography device that helps healthcare personnel to review, measure and analyse thermally significant indications in the breast region

Strides Pharma Science Limited announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Colchicine Tablets USP, 0.6 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Colcrys® Tablets, 0.6 mg, of Takeda Pharmaceuticals U.S.A., Inc. (Takeda).

Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 U/g/0.1%, of Taro Pharmaceuticals U.S.A. Inc. Nystatin and Triamcinolone

Lupin Limited announced the launch of Sevelamer Hydrochloride Tablets, 800 mg, having received an approval from the United States Food and Drug Administration (FDA). The product will be manufactured at Lupin's facility in Nagpur, India.

Sevelamer Hydrochloride Tablets, 800 mg is a generic equivalent of Renagel® Tablets, 800 mg of Genzyme Corporation.

CTI BioPharma Corp announced the U.S. Food and Drug Administration (FDA) has approved VONJO (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10⁹/L. VONJO is a novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK. The recommended dosage of VONJO is 200 mg orally twice daily.