Last Updated on October 14, 2024 by
Alembic Pharmaceuticals has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for doxycycline hyclate delayed-release tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg.
Alembic Pharma stated in a statement that the approved ANDA is therapeutically equivalent to the reference listed drug (RLD) product Doryx tablets, 75 mg, 100 mg, 150 mg, and 200 mg, by Mayne Pharma International, stated Alembic Pharma in a statement.
Doxycycline hyclate delayed-release tablets are indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of other antibacterial drugs.
These tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying anti-bacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy, the statement said.
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 the twelve months ending September 2021, as per IQVIA.
USFDA gives tentative nod to Zydus Cadila for Pimavanserin capsules
USFDA gives tentative nod to Amphastar Pharma for Vasopressin injection
USFDA gives nod to Granules India for Prazosin HCL capsules
USFDA gives nod to Lupin for this drug to treat Kidney disease
USFDA gives nod to Lupin generic Azilsartan Medoxomil tablets
USFDA authorises first oral antiviral to treat COVID
DCGI directs all State Drugs Controllers to implement ONDLS portal
DTAB recommends Bar code on top 300 brands of drug products
CDSCO panel gives nod to Takeda Pharma for Vadolizumab
Take measures to avoid mixing-up of vaccines in 15-18 age group
These 13 Pharma Companies to launch Anti-COVID Drug Molnupiravir
DCGI gives nod to Serum India for developing jab against Omicron
Common ET Plant to help pharma firms to treat or reuseโฆ
Pharma Firm booked for Rs 1,627 Crore Loan Fraud
Drug industry cheers FSSAIโs removal of ban on Methylcobalamin
Latest Notifications regarding Pharmaceuticals
