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India Business News: Aurobindo Pharma has received approval from the US Food & Drug Administration (USFDA) for its long-acting Granulocyte colony-stimulating factor (G-CSF

The product is bioequivalent and therapeutically equivalent to the reference listed drug Vascepa of Amarin. It will be manufactured at the companys facility in Bengaluru, it added. The Icosapent Ethyl capsules have a market size of around USD 1.3 billion, Strides said, citing IQVIA.

Zydus Lifesciences has gained the US Food and Drug Administrations (FDA) approval to produce and market its Indomethacin suppositories. The drug is used to treat moderate to severe rheumatoid arthritis and acute flares of chronic disease, among other conditions. Zydus has been awarded 180-day CGT exclusivity to market the product after US authorities deemed there was a lack of competition.

Pimavanserin is an atypical antipsychotic and is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

Alembic gets USFDA nod for generic hypertension treatment drug

The company has received approval from the US Food and Drug Administration (USFDA) to market in the US its generic version in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg, Zydus Cadila said in a statement.

Alembic Pharma gets USFDA nod for ophthalmic solution Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, used to treat certain types of glaucoma and other causes of high pressure inside the eye. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Cosopt Ophthalmic Solution, 2 percent and 0.5 percent, of Akorn Operating Company LL...

BDR Pharma gets FDA nod to distribute Remdesivir to Maharashtra BDR Pharmaceutical International had produced Remdesivir vials for export purpose but with FDA’s order it has been permitted to distribute strictly for Maharashtra Government supply or trade in the state only Mumbai: In a bid to address the shortage of Remdesivir vials, the Food and Drugs Administration (FDA) in its order has allowed the BDR Pharmaceutical International to distribute Remdesivir injections under emergency and v...

URL copied Zydus Cadila gets USFDA nod for thyroid drug Drug firm Zydus Cadila has received final approval from the US health regulator to market Liothyronine Sodium tablets that are used to treat underactive thyroid. Liothyronine is a man-made form of thyroid hormone which is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally made by the thyroid gland. Zydus Cadila has received final approval from the US Food and ...