USFDA

Alembic Pharmaceuticals Limited announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg.

The U.S. Food and Drug Administration approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.

The US Food and Drug Administration (FDA) has posted warning letters to 14 US companies that illegally sell more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without the approval of the FDA, most often on websites and social media

Alembic Pharmaceuticals Limited announced that the Company has received final approvals from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Olmesartan Medoxomil Tablets, 5 mg, 20mg and 40mg and Olmesartan Medoxomil with Hydrochlorothiazide Tablets 20/12.5mg, 40/12.5mg and 40/25mg.

Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it has launched Progesterone Capsules, 100 mg and 200 mg, a therapeutic equivalent generic version of Prometrium® (Progesterone) Capsules in the United States market, approved by the U.S. Food and Drug Administration (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.