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Alembic Pharma Doxycycline Hyclate Delayed-Release Tablets get USFDA okay

Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2022-01-04T09:30:00+05:30  |  Updated On 4 Jan 2022 4:00 AM GMT
Alembic Pharma Doxycycline Hyclate Delayed-Release Tablets get USFDA okay

The approved Doxycycline Hyclate delayed release tablets are therapeutically equivalent to the reference listed drug product (RLD) Doryx Tablets, 75 mg, 100 mg, 150 mg, and 200 mg, of Mayne Pharma International Pty Ltd (Mayne).

New Delhi: Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market Doxycycline Hyclate delayed-release tablets, used to treat drug resistant bacterial infections, in the American market.The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline...

New Delhi: Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market Doxycycline Hyclate delayed-release tablets, used to treat drug resistant bacterial infections, in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate delayed-release tablets, the drug firm said in regulatory filing.

Also Read: USFDA approves Alembic Pharma Dabigatran Etexilate Capsules

The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD) Doryx Tablets, 75 mg, 100 mg, 150 mg, and 200 mg, of Mayne Pharma International Pty Ltd (Mayne).

Doxycycline Hyclate delayed-release tablets are indicated to reduce the development of drug resistant bacteria.

According to IQVIA data, Doxycycline Hyclate delayed-release tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg have an estimated market size of USD 10 million for twelve months ending September 2021.

Also Read: Alembic Pharma gets USFDA nod for pulmonary arterial hypertension drug Selexipag

alembic pharma alembic pharma news USFDA Generic Drug Doryx mayne pharma Doxycycline Hyclate bacterial infections 
Source : PTI
Medical Dialogues Bureau
Medical Dialogues Bureau

    Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

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