USFDA

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted full approval for Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso is the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.

The U.S. Food and Drug Administration approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.

Cipla Ltd, a global pharmaceutical company, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Abacavir and Lamivudine Tablets USP, 600 mg/300 mg, from the United States Food and Drug Administration (USFDA).

U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.

The choice of President Donald Trump to head the US Food and Drug Administration is among the strongest advocates of lowering drug costs by quickly approving cheap generics, an initiative aimed directly at profit centers Of large companies.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem Injection 500 mg/vial and 1 g/vial. Aurobindo’s Meropenem injection is a generic equivalent of AstraZeneca Pharmaceuticals’ Merrem® Injection. The product will be launched immediately.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Abacavir Sulfate and Lamivudine tablets, 600 mg/300 mg. Aurobindo’s Abacavir Sulfate and Lamivudine tablets are the AB rated generic equivalent of VIIV Healthcare Company’s Epzicom tablets.

Timely action has stopped at least 1000kilos of fake cosmetics from coming on the market at a time when the demand for sunscreens are enormous. A Girgaum man has been prosecuted by the state Food and Drug Administration (FDA) for trying to sell spurious sunscreen tubes, filled with baby lotion, under the brand name of a reputed international cosmetics company.

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“Sun Pharma” and includes its subsidiaries or associate companies) was informed by the US FDA , that it will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements.