Moneycontrol
Get App
you are here: HomeNewsBusiness
Last Updated : Jan 15, 2020 11:15 AM IST | Source: PTI

Alembic Pharma gets USFDA nod for Tizanidine hydrochloride capsules used to treat spasticity

"The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing.

Representative image
Representative image
 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity.

"The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing.

Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity.

Close

Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important.

"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said.

Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 111 ANDA approval -- 99 final approvals and 12 tentative approvals -- from USFDA.

The shares of Alembic Pharmaceuticals Ltd were trading at Rs 573, up 1.96 percent on BSE in morning trade.

Get access to India's fastest growing financial subscriptions service Moneycontrol Pro for as little as Rs 599 for first year. Use the code "GETPRO". Moneycontrol Pro offers you all the information you need for wealth creation including actionable investment ideas, independent research and insights & analysis For more information, check out the Moneycontrol website or mobile app.
First Published on Jan 15, 2020 11:13 am
Sections
Follow us on
Available On